Class 2 Device Recall Magnus CarbonFibre Table Top

• Date Initiated by Firm: April 13, 2012
• Date Posted: July 30, 2012
• Recall Status: Terminated on September 04, 2013
• Recall Number: Z-2108-2012
• Recall Event ID: 62590
• Product Classification: Table, operating-room, ac-powered - Product Code FQO
• Product: Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16; ; The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
• Code Information: Model # 1180.16F2 Serial #s 1,3,7, & 8; Model # 1180.16F3 Serial # 1; Model #1180.16F5 Serial #4; Model # T285.7000 Serial #s 1,2,3,4, & 7.
• Recalling Firm/ Manufacturer: Maquet Medical Systems, Usa; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Ms. Susan Mandy; 201-995-8968
• Manufacturer Reason for Recall: As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012. There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.
• FDA Determined Cause: Device Design
• Action: MAQUET GETINGE Group sent An "Urgent Device Field Correction" notification, dated 13 April 2012 via Federal Express to all affected customers. An acknowledgement form is included with the customer letter which can be mailed or faxed back to Maquet Quality by the notified customers. If the completed Acknowledgement form is not received within 15 days, up to three follow ups will be made and documented via telephone call to each customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and notify their MAQUET Service Representative immediately. The MAQUET Service Representative will contact customers to make arrangements to replace both te logitudinal shift and tilt drives of their table top(s). For questions customers should call 888-627-8383, press option 2, followed by option 1. For questions regarding this recall call 201-995-8968.
• Quantity in Commerce: 164 Units located in 27 Countries
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.