FDA Device recall Z-2356-2024
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector by Med El Elektromedizinische Gereate, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2356-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Med El Elektromedizinische Gereate |
| Distribution | NC |
Product
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.
Identifiers
| code_info | a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 86…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2356-2024%22
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