Recall Z-2137-2019 ยท PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
MED-EL Elektromedizinische Gereate, Gmbh
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 evo
| Date | Oct 16, 2018 |
| Status | Terminated |
| Reason | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. |
| Root cause | Employee error |
| Action | Med-EL initially notified customers who had not yet implanted the affected devices on about 10/16/2018 via telephone call and followed up with an "Urgent-Medical Device Field Safety Notice (FSN)." The notice instructed customers to not implant the device if still available in inventory. Customers who had implanted the device were notified on about 11/27/2018 via telephone call and followed up with an "Urgent-Medical Device Field Safety Notice (FSN)." The notice instructed customers to immediately inform affected clinics of the recall and the long term risk. MED-EL does not recommend a de |
| Quantity | 10 devices |
| Distribution | Worldwide distribution - US Nationwide in the states of California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.