MED-EL Elektromedizinische Gereate, Gmbh: Device Recall
Recall #Z-2356-2024 · 04/18/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2356-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Status
- Ongoing
- Date Initiated
- 04/18/2024
- Location
- Innsbruck, Austria
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices
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.
Product Description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Distribution Pattern
US, Durham, NC
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.