Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
FDA device recall Z-0396-05 · posted 2005-01-15 · Terminated
Recall details
- Recalling firm
- Advanced Bionics Corporation
- Reason for recall
- A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
- Action taken
- Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.
- Root cause
- Other
- Status
- Terminated
- Product code
- LGW
- Quantity affected
- 237 patients are implanted.
- Distribution
- Nationwide
- Date initiated
- 2004-11-11
- Date posted
- 2005-01-15
- Date terminated
- 2005-03-08
- Location
- Sylmar, CA
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