Device product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Z-1813-2025
Product summary
- Event
- Event 96668
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 chargers
- Official record key
device-enforcement:Z-1813-2025
Official wording
Reason: Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Code information: M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967
Distribution pattern: U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Derived failure modes
-
Unknown
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.