MED EL Cochlear Implant System recall
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c.…
Why was MED EL Cochlear Implant System recalled?
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. SONATAti100 FLEXsoft, Serial Number 150489; b. SONATAti100 H Standard, Serial Numbers 146714, 164324; c. SONATAti100 Standard, Serial Numbers 145179, 217623, 144443, 145228, 158919, 147748, 223013.
- Product
- MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c.…
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- 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.
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)