Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Coc
FDA device recall Z-2356-2024 · posted 2024-07-12 · Open, Classified
Recall details
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Reason for recall
- 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.
- Action taken
- MED-EL issued an Urgent-Medical Device Field Safety Notice (FSN) Medical Device Return notice to its sole US consignee (distributor) on 04/18/2024 via email. The notice explained the problem with the device and requested the return of all affected devices.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MCM
- Quantity affected
- 7 devices
- Distribution
- US, Durham, NC
- Date initiated
- 2024-04-18
- Date posted
- 2024-07-12
- Location
- Innsbruck, Austria
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