FDA-Device2019-04-10Class II
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.
Advanced Bionics, LLC
Hazard
The sound processors were loaded with the incorrect firmware.
Sold states
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.
Affected count
3 sound processors
Manufactured in
28515 Westinghouse Pl, N/A, Valencia, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1084-2019Don't want to check this manually?
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