Advanced Bionics Corporation Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
Brand
Advanced Bionics Corporation
Lot Codes / Batch Numbers
All Codes
Products Sold
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Advanced Bionics Corporation is recalling Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System due to A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026