FDA-Device2024-07-24Class II
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
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.
Sold states
US, Durham, NC
Affected count
7 devices
Manufactured in
Furstenweg 77a, Innsbruck, Austria
Products
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2356-2024Don't want to check this manually?
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