| 2026-04-30 |
Class II
|
Ongoing |
Z-2304-2026 |
BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2303-2026 |
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2302-2026 |
BD Pyxis MedStation ES Tower REF: 352 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2301-2026 |
BD Pyxis Mini Main REF: 349 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2300-2026 |
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2299-2026 |
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2298-2026 |
BD Pyxis MedStation ES REF: 323 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-04-30 |
Class II
|
Ongoing |
Z-2297-2026 |
BD Pyxis MedStation 4000 REF: 303 Medication cabinet |
— |
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. |
| 2026-02-11 |
Class II
|
Ongoing |
Z-1645-2026 |
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit |
— |
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communicatio… |
| 2025-12-03 |
Class II
|
Ongoing |
Z-1028-2026 |
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, … |
— |
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. |
| 2025-11-20 |
Class II
|
Ongoing |
Z-0962-2026 |
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower… |
— |
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a … |
| 2025-11-06 |
Class II
|
Ongoing |
Z-1217-2026 |
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a … |
— |
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospit… |
| 2025-10-17 |
Class I
|
Ongoing |
Z-0430-2026 |
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,… |
— |
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, … |
| 2025-09-30 |
Class II
|
Ongoing |
Z-0371-2026 |
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2025-09-30 |
Class II
|
Ongoing |
Z-0370-2026 |
BD Pyxis Pro MedStation Main, REF: 1155-00 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2025-09-30 |
Class II
|
Ongoing |
Z-0369-2026 |
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2025-09-30 |
Class II
|
Ongoing |
Z-0368-2026 |
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 13… |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2025-09-30 |
Class II
|
Ongoing |
Z-0367-2026 |
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-… |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2025-09-11 |
Class I
|
Ongoing |
Z-0035-2026 |
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron … |
— |
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstre… |
| 2025-07-10 |
Class III
|
Ongoing |
Z-2321-2025 |
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH… |
— |
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow. |
| 2025-07-08 |
Class I
|
Ongoing |
Z-2180-2025 |
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60… |
— |
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstre… |
| 2025-07-08 |
Class I
|
Ongoing |
Z-2179-2025 |
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions |
— |
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstre… |
| 2025-05-08 |
Class II
|
Ongoing |
Z-2477-2025 |
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" … |
— |
Antivirus software was not consistently installed on impacted devices during the implementation process. |
| 2025-05-08 |
Class II
|
Ongoing |
Z-2017-2025 |
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4… |
— |
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed thi… |
| 2025-03-11 |
Class II
|
Ongoing |
Z-1639-2025 |
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-… |
— |
Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue th… |
| 2025-03-11 |
Class II
|
Ongoing |
Z-1550-2025 |
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01… |
— |
Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item… |
| 2025-03-11 |
Class II
|
Ongoing |
Z-1545-2025 |
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen… |
— |
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction … |
| 2025-02-18 |
Class I
|
Ongoing |
Z-1305-2025 |
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software |
— |
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 2025-02-18 |
Class I
|
Ongoing |
Z-1304-2025 |
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software |
— |
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). |
| 2025-02-06 |
Class II
|
Ongoing |
Z-1375-2025 |
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF… |
— |
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that… |
| 2025-01-23 |
Class II
|
Ongoing |
Z-1231-2025 |
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorin… |
— |
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue pot… |
| 2025-01-23 |
Class II
|
Ongoing |
Z-1207-2025 |
BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing… |
— |
Due to fingerprint scanner failing resulting in the scanner heating up. |
| 2025-01-10 |
Class II
|
Ongoing |
Z-1206-2025 |
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis use… |
— |
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retr… |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1230-2025 |
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2H… |
— |
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1229-2025 |
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2… |
— |
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1228-2025 |
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 13… |
— |
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1227-2025 |
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI … |
— |
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1120-2025 |
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta… |
— |
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1119-2025 |
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES… |
— |
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthor… |
| 2024-11-14 |
Class II
|
Ongoing |
Z-0672-2025 |
BD Pyxis CII Safe ES, REF: 1116-00 |
— |
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medica… |
| 2024-11-14 |
Class II
|
Ongoing |
Z-0671-2025 |
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 |
— |
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medica… |
| 2024-11-14 |
Class II
|
Ongoing |
Z-0670-2025 |
BD Pyxis MedStation ES, REF: 323 |
— |
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medica… |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3142-2024 |
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system |
— |
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3141-2024 |
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system |
— |
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3140-2024 |
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system |
— |
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3139-2024 |
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system |
— |
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| 2024-08-15 |
Class II
|
Ongoing |
Z-3138-2024 |
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system |
— |
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. |
| 2024-07-09 |
Class II
|
Ongoing |
Z-2948-2024 |
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medi… |
| 2024-07-09 |
Class II
|
Ongoing |
Z-2947-2024 |
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medi… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2503-2024 |
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2502-2024 |
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2501-2024 |
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2500-2024 |
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2499-2024 |
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2498-2024 |
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2497-2024 |
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2496-2024 |
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2495-2024 |
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2494-2024 |
BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2493-2024 |
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2492-2024 |
BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2491-2024 |
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2490-2024 |
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2489-2024 |
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2488-2024 |
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2487-2024 |
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2486-2024 |
BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-06-24 |
Class II
|
Ongoing |
Z-2485-2024 |
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9 |
— |
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for… |
| 2024-05-21 |
Class II
|
Ongoing |
Z-2262-2024 |
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units |
— |
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. |
| 2024-05-13 |
Class II
|
Ongoing |
Z-2256-2024 |
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1… |
— |
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission … |
| 2024-05-13 |
Class II
|
Ongoing |
Z-2255-2024 |
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ … |
— |
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission … |
| 2024-05-02 |
Class II
|
Ongoing |
Z-2374-2024 |
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES… |
— |
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was in… |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1932-2024 |
BD Pyxis(TM) Anesthesia Station 4000, REF: 338 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1931-2024 |
BD Pyxis" Anesthesia Station ES, REF: 327 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1930-2024 |
BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1929-2024 |
BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1928-2024 |
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1927-2024 |
BD Pyxis MedStation ES, REF: 323, Medication Cabinet |
— |
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1125-2025 |
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he… |
— |
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in acces… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1124-2025 |
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut… |
— |
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in acces… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1123-2025 |
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho… |
— |
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in acces… |
| 2024-02-23 |
Class II
|
Ongoing |
Z-1122-2025 |
BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and… |
— |
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in acces… |
| 2024-02-01 |
Class II
|
Ongoing |
Z-1223-2024 |
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352; |
— |
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, whi… |
| 2023-10-05 |
Class II
|
Ongoing |
Z-1552-2025 |
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK … |
— |
If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring … |
| 2023-09-15 |
Class I
|
Ongoing |
Z-0186-2024 |
Alaris PCA Module 8120 |
— |
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| 2023-09-15 |
Class I
|
Ongoing |
Z-0185-2024 |
BD Alaris Syringe Module, REF 8110 |
— |
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| 2023-09-15 |
Class I
|
Ongoing |
Z-0184-2024 |
BD Alaris PCU REF 8015 |
— |
Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0093-2024 |
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desk… |
— |
When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destructio… |
| 2023-08-18 |
Class II
|
Ongoing |
Z-2646-2023 |
BD Pyxis MedBank MedPass Software, REF: 139088-01 |
— |
After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is … |
| 2023-05-22 |
Class II
|
Ongoing |
Z-2094-2023 |
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224… |
— |
Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose us… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-1579-2023 |
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesi… |
— |
Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss… |
| 2023-04-05 |
Class II
|
Ongoing |
Z-0906-2025 |
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 |
— |
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a mul… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-1207-2023 |
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES… |
— |
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or … |
| 2023-02-14 |
Class II
|
Ongoing |
Z-1050-2025 |
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES … |
— |
Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancie… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-0976-2025 |
BD Pyxis Med 4000 Auxiliary (AUX), REF 314 |
— |
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur hav… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-0975-2025 |
BD Pyxis Med ES Auxiliary (AUX), REF 343 |
— |
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur hav… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-0974-2025 |
BD Pyxis MedStation 4000 AUX, REF 306 |
— |
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur hav… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-0973-2025 |
BD Pyxis MedStation 4000 Main, REF 303 |
— |
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur hav… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-0972-2025 |
BD Pyxis MedStation ES AUX, REF 324 |
— |
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur hav… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-0971-2025 |
BD Pyxis MedStation ES (Med ES Main), REF 323 |
— |
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur hav… |
| 2023-01-24 |
Class II
|
Ongoing |
Z-1192-2023 |
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x… |
— |
Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets … |
| 2022-12-12 |
Class II
|
Ongoing |
Z-0928-2023 |
BD Pyxis MedBank System - Product Label/labeling pending |
— |
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is phys… |
| 2022-05-24 |
Class II
|
Ongoing |
Z-1785-2022 |
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex op… |
— |
The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cab… |
| 2021-03-03 |
Class I
|
Ongoing |
Z-1309-2021 |
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Mo… |
— |
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for progr… |
| 2020-08-04 |
Class I
|
Ongoing |
Z-2939-2020 |
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346… |
— |
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or int… |
| 2020-08-04 |
Class II
|
Ongoing |
Z-2935-2020 |
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon … |
— |
Infusion pump component defect may result in interruption of patient monitoring |
| 2020-08-04 |
Class I
|
Ongoing |
Z-2910-2020 |
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE … |
— |
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, … |
| 2020-08-04 |
Class I
|
Ongoing |
Z-2909-2020 |
Alaris System PC Unit Model 8015 |
— |
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, … |
| 2020-08-04 |
Class I
|
Ongoing |
Z-2882-2020 |
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System… |
— |
The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion. |
| 2020-06-30 |
Class II
|
Ongoing |
Z-2826-2020 |
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way… |
— |
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| 2020-06-30 |
Class II
|
Ongoing |
Z-2825-2020 |
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate t… |
— |
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| 2020-06-30 |
Class II
|
Ongoing |
Z-2824-2020 |
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the… |
— |
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| 2020-06-30 |
Class II
|
Ongoing |
Z-2823-2020 |
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate… |
— |
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| 2020-06-30 |
Class II
|
Ongoing |
Z-2822-2020 |
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate th… |
— |
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. |
| 2020-06-30 |
Class I
|
Terminated |
Z-2741-2020 |
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system |
— |
If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the syste… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2740-2020 |
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system |
— |
If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the syste… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2736-2020 |
Alaris Pump Module Model 8100 |
— |
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2723-2020 |
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2722-2020 |
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2721-2020 |
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2720-2020 |
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2719-2020 |
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2718-2020 |
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2717-2020 |
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-06-30 |
Class I
|
Terminated |
Z-2716-2020 |
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system |
— |
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which ma… |
| 2020-02-04 |
Class I
|
Ongoing |
Z-1362-2020 |
CareFusion Alaris PCA Module, Model 8120 |
— |
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in… |
| 2020-02-04 |
Class I
|
Ongoing |
Z-1361-2020 |
CareFusion Alaris Syringe Module, Model 8110 |
— |
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in… |
| 2020-02-04 |
Class I
|
Ongoing |
Z-1360-2020 |
CareFusion Alaris Pump Module, Model 8100 |
— |
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in… |
| 2020-02-04 |
Class I
|
Ongoing |
Z-1359-2020 |
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) |
— |
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in… |