Device 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.
Z-0486-2021
Product summary
- Event
- Event 86536
- Status
- Terminated
- Classification
- Class III
- Quantity
- 53 units
- Official record key
device-enforcement:Z-0486-2021
Official wording
Reason: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Code information: 410079020
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
Mislabeling