Class II
Medical Device Recall: Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
MED-EL Elektromedizinische Gereate, Gmbh · April 18, 2024
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.
Distribution
US, Durham, NC
States Affected
NC
Quantity Affected
7 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2356-2024
Status: ongoing
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