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Recall Observatory FDA recall evidence

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

September 26, 2020

Class III

Product summary

Firm
Advanced Bionics, LLC
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

    reason.labeling_packaging · v1.0.0

    Mislabeling