Recall Z-0943-04 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Biotronik Inc
Tachos ATx
| Date | Jul 20, 2004 (initiated Apr 29, 2004) |
| Status | Terminated |
| Reason | Potential for device to not deliver full amount of energy |
| Root cause | Other |
| Action | On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated. |
| Quantity | 50 |
| Distribution | Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.