Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used t

FDA device recall Z-0627-2013 · posted 2013-01-03 · Terminated

Recall details

Recalling firm

Maquet Inc.

Reason for recall

There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FWZ

Quantity affected

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, Jap

Date initiated

2012-11-02

Date posted

2013-01-03

Date terminated

2013-08-21

Location

Wayne, NJ