FDA-Device2025-05-28Class II
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Advanced Bionics, LLC
Hazard
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Sold states
U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Affected count
6 chargers
Manufactured in
28515 Westinghouse Pl, N/A, Valencia, CA, United States
Products
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2025Don't want to check this manually?
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