Advanced Bionics, LLC recalls Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
- Recall date
- February 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1085-2019
- 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 Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
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