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U.S. Department of Health and Human Services

Class 3 Device Recall PowerCell 230

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 Class 3 Device Recall PowerCell 230see related information
Date Initiated by FirmSeptember 26, 2020
Date PostedNovember 25, 2020
Recall Status1 Terminated 3 on May 04, 2023
Recall NumberZ-0486-2021
Recall Event ID 86536
Product Classification Implant, cochlear - Product Code MCM
ProductAB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260) for cochlear implant.
Code Information 410079020
Recalling Firm/
Manufacturer		 Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information ContactMs. Kaitlin Farrell
661-362-4631
Manufacturer Reason
for Recall		Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 9/26/2020 Advanced Bionics sent a "Field Correction Notification" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees. In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery.
Quantity in Commerce53 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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