Deikos A+
FDA device recall Z-0944-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Biotronik Inc
- Reason for recall
- Potential for device to not deliver full amount of energy
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 6
- Distribution
- Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
- Date initiated
- 2004-04-29
- Date posted
- 2004-07-20
- Date terminated
- 2006-04-21
- Location
- Lake Oswego, OR
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