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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62590
Product Type Devices
Status Ongoing
Recalling Firm Maquet Medical Systems, Usa
City Wayne
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II 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. 164 Units located in 27 Countries Z-2108-2012
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