Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table

FDA device recall Z-2108-2012 · posted 2012-07-30 · Terminated

Recall details

Recalling firm

Maquet Medical Systems, Usa

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FQO

Quantity affected

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, Irelan

Date initiated

2012-04-13

Date posted

2012-07-30

Date terminated

2013-09-04

Location

Wayne, NJ