PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: December 2, 2020 Initiated: September 26, 2020 #Z-0486-2021

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.

Details

Recalling Firm
Advanced Bionics, LLC
Units Affected
53 units
Distribution
Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.
Location
Valencia, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Advanced Bionics, LLC. Units affected: 53 units.
Why was this product recalled?
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 2, 2020. Severity: Low. Recall number: Z-0486-2021.