FDA recall Z-1085-2019

Advanced Bionics, LLC · Class II · device

Product

Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.

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.

Key facts

Status
Terminated
Initiation date
2019-02-06
Report date
2019-04-10
Termination date
2024-02-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2019