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U.S. Department of Health and Human Services

Class 2 Device Recall Nada CI Q70 Sound Processor

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  Class 2 Device Recall Nada CI Q70 Sound Processor see related information
Date Initiated by Firm February 06, 2019
Create Date April 03, 2019
Recall Status1 Open3, Classified
Recall Number Z-1084-2019
Recall Event ID 82241
PMA Number P960058 
Product Classification Implant, cochlear - Product Code MCM
Product Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Code Information Model Cl-5245-120 - Serial number 1042838, UDI (01)07630016837814(11)150729(21)1042838;  Model Cl-5245-140 - Serial number 1013129, UDI (01)07630016838262(11)181030(21)1013129; and  Model Cl-5245-150 - Serial number 1033132, UDI (01)07630016838279(11)170525(21)1033132.  
Recalling Firm/
Manufacturer
Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information Contact Ms. Carol Abernathy
661-362-7580
Manufacturer Reason
for Recall
The sound processors were loaded with the incorrect firmware.
FDA Determined
Cause 2
Process control
Action On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
Quantity in Commerce 3 sound processors
Distribution Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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