Advanced Bionics, LLC recalls Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl…

Recall date

February 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1084-2019

FDA classification

Class II

Brand / firm

Advanced Bionics, LLC

Sold / distributed

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.

Why it was recalled

The sound processors were loaded with the incorrect firmware.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.