Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
- Company
- Advanced Bionics, Llc
- Recall Initiated
- February 6, 2019
- Terminated
- February 1, 2024
- Recall Number
- Z-1083-2019
- Quantity
- 4 sound processors
- Firm Location
- Valencia, CA
Reason for Recall
The sound processors were loaded with the incorrect firmware.
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
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