Recall Z-2108-2012— Maquet Medical Systems, Usa

Class II FDA medical device recall by Maquet Medical Systems, Usa, initiated 2012-04-13, terminated 2013-09-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Maquet Medical Systems, Usa

Classification

Class II

Status

Terminated

Initiated

2012-04-13

Terminated

2013-09-04

Firm location

Wayne, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.