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U.S. Department of Health and Human Services

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 Class 2 Recall
Maquet Yuno Extension Table Device		see related information
Date Posted January 03, 2013
Recall Number Z-0627-2013
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.
Code Information Class I exempt Device Listing Number A922956
Recalling Firm/
Manufacturer		 Maquet Inc.
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Ms. Susan Mandy
973-709-7660
Reason for
Recall		 There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Action Maquet sent Urgent Product Field Correction letters/Field Correction Confirmation Form dated November 2, 2012 on November 15, 2012, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a MAQUET authorized Service Technicians would contact them to arrange an appointment to assess their device and to replace the release lever at no cost to them at their facility. Customers were asked to completed and return the enclosed confirmation form, acknowledging their receipt and understanding of the communication, in the enclosed postage prepaid envelope, by e-mailing a scanned copy to FieldActions@maquet.com or via fax at 973-709-6508. For questions customers were instructed to call MAQUET Technical Support at 800-777-4222, Press option2, followed by option 2. For questions regarding this recall call 973-709-7660.
Quantity in Commerce 63 devices
Distribution 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.
 
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