FDA Enforcement
Class II
Ongoing
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Recall: Z-2356-2024
·
Reported July 24, 2024
Enforcement
- Recall Number
- Z-2356-2024
- Event ID
- 94531
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 24, 2024
- Initiation Date
- April 18, 2024
- Classification Date
- July 12, 2024
- Address
- Furstenweg 77a, Innsbruck, N/A, Austria
Description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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 Info
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
US, Durham, NC
Quantity
7 devices