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Z-2108-2012 Class II Terminated

Recalled by Maquet Medical Systems, Usa — Wayne, NJ

FDA device recall Z-2108-2012 was initiated by Maquet Medical Systems, Usa on April 13, 2012 and is designated Class II. 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… The recall status is terminated (terminated September 4, 2013). Affected quantity: 164 Units located in 27 Countries.

Recall Details

Product Type: Devices
Report Date: August 8, 2012
Initiation Date: April 13, 2012
Termination Date: September 4, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 164 Units located in 27 Countries

Product Description

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.

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.

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.

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.