FDA Medical Device Recalls (openFDA)
Advanced Bionics Corporation: Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
- Recall number
- Z-0396-05
- Recalling firm
- Advanced Bionics Corporation
- Product
- Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
- Status
- Terminated
- Initiated
- 2004-11-11
- Posted
- 2005-01-15
- Terminated
- 2005-03-08
- Reason
- A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
- Root cause
- Other
- Action
- 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.
- Quantity
- 237 patients are implanted.
- Distribution
- Nationwide
- Lot, serial or model codes
- All Codes
- 510(k) numbers
- not on file
- PMA numbers
- ["P030017"]
- Product code
- LGW
- Firm FEI
- 1000220815
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28