Device product
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Z-1493-2026
Product summary
- Event
- Event 98161
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1493-2026
Official wording
Reason: Behind-the-ear sound processer packaging label is different then included product.
Code information: Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
Distribution pattern: Unknown
Derived failure modes
-
Unknown
Behind-the-ear sound processer packaging label is different then included product.