FDA-Device2013-01-09Class II
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.
Maquet Inc.
Hazard
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Sold states
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.
Affected count
63 devices
Manufactured in
45 Barbour Pond Drive, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0627-2013Don't want to check this manually?
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