| 2025-11-26 |
Class II
|
Ongoing |
Z-1027-2026 |
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel … |
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Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If … |
| 2025-05-30 |
Class II
|
Ongoing |
Z-2175-2025 |
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an ac… |
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Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope is… |
| 2025-04-16 |
Class II
|
Ongoing |
Z-1666-2025 |
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 … |
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software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. |
| 2025-04-15 |
Class II
|
Ongoing |
Z-1729-2025 |
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 |
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Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freez… |
| 2024-10-28 |
Class III
|
Ongoing |
Z-0557-2025 |
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in man… |
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Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| 2024-05-09 |
Class II
|
Ongoing |
Z-2028-2024 |
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual |
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Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may… |
| 2023-08-24 |
Class II
|
Ongoing |
Z-2625-2023 |
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used Wit… |
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Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, inform… |
| 2023-05-08 |
Class II
|
Ongoing |
Z-1825-2023 |
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 |
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Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing w… |
| 2023-02-23 |
Class II
|
Ongoing |
Z-1321-2023 |
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified p… |
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During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues. |
| 2022-01-28 |
Class II
|
Terminated |
Z-0861-2022 |
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 |
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Distribution of Defibrillators that are not approved or cleared for distribution US Market. |
| 2021-05-25 |
Class II
|
Ongoing |
Z-1997-2021 |
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R,… |
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The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged. |
| 2020-11-17 |
Class II
|
Terminated |
Z-0564-2021 |
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended… |
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A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the … |