Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Reported: July 24, 2024 Initiated: April 18, 2024 #Z-2356-2024
Product Description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
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.
Details
- Recalling Firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Units Affected
- 7 devices
- Distribution
- US, Durham, NC
- Location
- Innsbruck
Frequently Asked Questions
What product was recalled? ▼
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant. Recalled by MED-EL Elektromedizinische Gereate, Gmbh. Units affected: 7 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2356-2024.
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