| 2025-03-18 |
Class II
|
Ongoing |
Z-1694-2025 |
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22… |
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It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information… |
| 2025-03-18 |
Class II
|
Ongoing |
Z-1693-2025 |
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) |
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It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information… |
| 2025-03-18 |
Class II
|
Ongoing |
Z-1692-2025 |
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310… |
— |
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information… |
| 2025-03-18 |
Class II
|
Ongoing |
Z-1691-2025 |
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22… |
— |
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information… |
| 2025-03-18 |
Class II
|
Ongoing |
Z-1690-2025 |
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D… |
— |
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information… |
| 2024-10-14 |
Class II
|
Ongoing |
Z-0505-2025 |
Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline E… |
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Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authori… |
| 2024-10-14 |
Class II
|
Ongoing |
Z-0504-2025 |
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, … |
— |
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authori… |
| 2024-10-14 |
Class II
|
Ongoing |
Z-0503-2025 |
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Serie… |
— |
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authori… |
| 2024-10-14 |
Class II
|
Ongoing |
Z-0502-2025 |
Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indi… |
— |
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized l… |
| 2024-07-12 |
Class I
|
Ongoing |
Z-2543-2024 |
RMU-2000 Automated Chest Compression Device |
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Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to p… |
| 2023-02-14 |
Class II
|
Ongoing |
Z-1312-2023 |
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest |
— |
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device… |
| 2020-04-27 |
Class II
|
Terminated |
Z-2394-2020 |
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A… |
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A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fai… |
| 2020-04-27 |
Class II
|
Terminated |
Z-2393-2020 |
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for u… |
— |
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fai… |
| 2020-04-27 |
Class II
|
Terminated |
Z-2392-2020 |
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-… |
— |
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fai… |