Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Nada CL Q30 Sound Processor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Nada CL Q30 Sound Processorsee related information
Date Initiated by FirmFebruary 06, 2019
Create DateApril 03, 2019
Recall Status1 Terminated 3 on February 01, 2024
Recall NumberZ-1083-2019
Recall Event ID 82241
PMA NumberP960058 
Product Classification Implant, cochlear - Product Code MCM
ProductNada 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 ContactMs. Carol Abernathy
661-362-7580
Manufacturer Reason
for Recall		The sound processors were loaded with the incorrect firmware.
FDA Determined
Cause 2		Process control
ActionOn 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
Quantity in Commerce4 sound processors
DistributionDistribution 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 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.
PMA DatabasePMAs with Product Code = MCM
-
-