Recall Z-0486-2021— Advanced Bionics, LLC
Class III · Terminated
Class III FDA medical device recall by Advanced Bionics, LLC, initiated 2020-09-26, terminated 2023-05-04. FDA's recall record names no specific 510(k) clearance for this event. Product: AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.. Reason: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated..
- Recalling firm
- Advanced Bionics, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-09-26
- Terminated
- 2023-05-04
- Firm location
- Valencia, CA, United States
Product description
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.
Reason for recall
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.