Company: Advanced Bionics, LLC
Date of Enforcement Report: 4/10/2019
Class II:
PRODUCT
Naida CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Recall Number: Z-1083-2019
Naida CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Recall Number: Z-1084-2019
Naida CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Recall Number: Z-1085-2019
REASON
The sound processors were loaded with the incorrect firmware.
RECALLING FIRM/MANUFACTURER
Advanced Bionics, LLC on 2/6/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4 sound processors
DISTRIBUTION
North Carolina (US) and International