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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.