Defibtech, LLC Recall 91799
Description: DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Defibtech, LLC Recall 91799 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1312-2023 |
| Event ID | 91799 |
| Event Description | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 29 units |
| Recall Reason | 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 could fail to deliver therapy. |
| Device Classification | 20230405 |
| Device Code Info | UDI-DI: 00815098020003 Serial Numbers: 101702198 101702263 101702424 101702524 101702535 101702540 101702544 101702545 101703267 101703269 101703272 101703274 101703276 101703277 101703278 101703281 101703312 101703326 101703378 101703407 101703411 101703412 101703419 101703424 101703427 101703464 101703465 101703600 101704106 |
| Center Classification Date | 20230330 |
| Recall Initiation Date | 20230214 |
| Recalling Firm | Defibtech, LLC |
| Initial Notification | |
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