FDAFDA · Food and drugs·Recall number Z-2356-2024
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Published July 24, 2024 · Recall initiated: April 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- MED-EL Elektromedizinische Gereate, Gmbh
- Distributor
- US, Durham, NC
- Lot
- a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Austria
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