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MED-EL Elektromedizinische Gereate, Gmbh recalls Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vect
Recalled July 24, 2024 · FDA recall Z-2356-2024 · MED-EL Elektromedizinische Gereate
Hazard
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. · FDA Class II
Units
7 devices
Sold at
US, Durham, NC
Description
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
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Manufacturer(s)
MED-EL Elektromedizinische Gereate, Gmbh
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →