Reported Aug 14, 2019 · Terminated
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types
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 · N/A
Is this the product you have?
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types
3 of 3 products
| # | Product as published |
|---|---|
| 1 | SONATAti100 FLEXsoft |
| 2 | SONATAti100 H Standard |
| 3 | SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. |
- Lot codes and dates
a. SONATAti100 FLEXsoftSerial Number 150489b. SONATAti100 H StandardSerial Numbers 146714164324c. SONATAti100 StandardSerial Numbers 145179217623144443145228158919147748223013
- Amount recalled
- 10 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
This product could cause temporary or reversible health problems — stop using it.
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