FDA Recall
Open, Classified
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Recall: Z-2356-2024
·
Initiated April 18, 2024
Recall
- Recall Number
- Z-2356-2024
- Event Number
- 94531
- Firm
- MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria
- FEI Number
- 3000249315
- Product Code
- MCM
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 18, 2024
- Posted
- July 12, 2024
Description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Reason
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.
Action
MED-EL issued an Urgent-Medical Device Field Safety Notice (FSN) Medical Device Return notice to its sole US consignee (distributor) on 04/18/2024 via email. The notice explained the problem with the device and requested the return of all affected devices.
Distribution
US, Durham, NC
Quantity
7 devices