FDA Device

Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

Hazard

The sound processors were loaded with the incorrect firmware.

What You Should Do

Remedy

On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.

Products

Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Brand
Advanced Bionics, LLC
UPC
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.

Units Affected

4 sound processors