Device product
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Z-2356-2024
Product summary
- Event
- Event 94531
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 devices
- Official record key
device-enforcement:Z-2356-2024
Official wording
Reason: A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
Code information: a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386
Distribution pattern: US, Durham, NC
Derived failure modes
-
Unknown
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.