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-Vector; Co…
- Recall date
- April 18, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2356-2024
- FDA classification
- Class II
- Brand / firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Sold / distributed
- US, Durham, NC
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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