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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