Device product
Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.
Z-0627-2013
Product summary
- Firm
- Maquet Inc.
- Event
- Event 63878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63 devices
- Official record key
device-enforcement:Z-0627-2013
Official wording
Reason: There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Code information: Class I exempt Device Listing Number A922956
Distribution pattern: Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.
Derived failure modes
-
Unknown
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.