MED-EL Elektromedizinische Gereate, Gmbh: Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

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.

Details from the source

Reason for recall: 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. Distribution: US, Durham, NC Quantity: 7 devices Lot/code info: 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

UPC codes

09008737395414, 09008737395452, 09008737395476

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.