Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
FDA device recall Z-0076-04 · posted 2003-10-31 · Terminated
Recall details
- Recalling firm
- Biotronik Inc
- Reason for recall
- Potential for early depletion of Implantable Cardioverter Defibrillator battery.
- Action taken
- Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 794 devices
- Distribution
- The firm distributes to physicians located throughout the US.
- Date initiated
- 2003-09-24
- Date posted
- 2003-10-31
- Date terminated
- 2005-02-17
- Location
- Lake Oswego, OR
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