Recall Z-0077-04 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Biotronik Inc
Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
| Date | Oct 31, 2003 (initiated Sep 24, 2003) |
| Status | Terminated |
| Reason | Potential for early depletion of Implantable Cardioverter Defibrillator battery. |
| Root cause | Other |
| Action | Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices. |
| Quantity | 272 devices |
| Distribution | The firm distributes to physicians located throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.