Reported Jul 24, 2024 · Ongoing
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector;…
MED-EL Elektromedizinische Gereate, GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MED-EL Elektromedizinische Gereate, Gmbh · Furstenweg 77a · Innsbruck · N/A
Is this the product you have?
- Mi1250 SYNCHRONY 2
- Item Numbers
a) 39541FLEXSOFT S-Vectorb) 39545FLEX28 S-Vectorc) 39547FLEX26 S-VectorCochlear Implant
- Lot codes and dates
a) 39541UDI/DI 09008737395414
- Serial Numbers
859106b) 39545UDI/DI 09008737395452
- Serial Numbers
860731860782863380c) 39547UDI/DI 09008737395476
- Serial Numbers
860757860772863386
- Amount recalled
- 7 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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