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U.S. Department of Health and Human Services

Class 3 Device Recall PowerCell 170

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  Class 3 Device Recall PowerCell 170 see related information
Date Initiated by Firm September 26, 2020
Date Posted November 25, 2020
Recall Status1 Terminated 3 on May 04, 2023
Recall Number Z-0487-2021
Recall Event ID 86536
Product Classification Implant, cochlear - Product Code MCM
Product 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.
Code Information 410078519
Recalling Firm/
Manufacturer		 Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information Contact Ms. 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
Action On 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 Commerce 28 units
Distribution 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.
Total Product Life Cycle TPLC 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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