Recall – Cochlear implant sound processor loaded with incorrect firmware

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

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