FDA-Device2020-12-02Class III
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 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.
Advanced Bionics, LLC
Hazard
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Sold states
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.
Affected count
28 units
Manufactured in
28515 Westinghouse Pl, N/A, Valencia, CA, United States
Products
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2021Don't want to check this manually?
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