Recall Z-2356-2024— MED-EL Elektromedizinische Gereate, Gmbh
Class II · Ongoing
Class II FDA medical device recall by MED-EL Elektromedizinische Gereate, Gmbh, initiated 2024-04-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-18
- Firm location
- Innsbruck, Austria
Product description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.