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U.S. Department of Health and Human Services

Class 2 Device Recall Nada CL Q30 Sound Processor

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  Class 2 Device Recall Nada CL Q30 Sound Processor see related information
Date Initiated by Firm February 06, 2019
Create Date April 03, 2019
Recall Status1 Terminated 3 on February 01, 2024
Recall Number Z-1083-2019
Recall Event ID 82241
PMA Number P960058 
Product Classification Implant, cochlear - Product Code MCM
Product Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Code Information Model Cl-5260-120 - Serial number 1047584, UDI (01)07630016838057(11)180309(21)1045784;   Model Cl-5260-140 - Serial number 1047481, UDI (01)07630016829710(11)151208(21)1047481; and Serial number 1047482, UDI (01)07630016829710(11)151208(21)1047482; and  Model Cl-5260-150 - Serial number 1082276, UDI (01)07630016838071(11)180925(21)1082276.
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 4 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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