Recall Z-2137-2019— MED-EL Elektromedizinische Gereate, Gmbh
Class II · Terminated
Class II FDA medical device recall by MED-EL Elektromedizinische Gereate, Gmbh, initiated 2018-10-16, terminated 2020-05-22. FDA's recall record names no specific 510(k) clearance for this event. Product: MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. 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.. Reason: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification..
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-16
- Terminated
- 2020-05-22
- Firm location
- Innsbruck, N/A, Austria
Product description
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. 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.
Reason for recall
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.