Recall Z-0073-04 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Biotronik Inc
Belos DR-T Implantable Cardioverter Defibrillator
| Date | Oct 31, 2003 (initiated Sep 24, 2003) |
| Status | Terminated |
| Reason | Potential extended charge time anomalies. |
| Root cause | Other |
| Action | Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up with affected patients. |
| Quantity | 43 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.