Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremiti

FDA device recall Z-1045-2016 · posted 2016-03-03 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down.

Action taken

Maquet sent "URGENT PRODUCT RECALL MEDICAL DEVICE CORRECTION" letters/MEDICAL DEVICE CORRECTION RESPONSE FORM dated January 7, 2016, via UPS to the affected customers. The notification informed customers of the issue with the affected product; how to identify affected product; measures to be taken by the users; and that a MAQUET service representative will be contacting them to schedule servicing of the device to install a Support Frame Lock. Customers with questions were asked to contact their local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Option 2, Option 3) Monday through Friday between 8:00 am and 5:00 pm EDT. Customers were also requested to fill out and return the attached response forms.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FQO

Quantity affected

2 within US; 247 OUS

Distribution

Worldwide Distribution - US including AZ and MO. Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, It

Date initiated

2016-01-07

Date posted

2016-03-03

Date terminated

2017-05-25

Location

Wayne, NJ