Advanced Bionics, LLC: Medical Device Recall in 2020 - (Recall #: Z-0486-2021)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class III
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
410079020
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.
Voluntary: Firm initiated