Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US marke

FDA device recall Z-2238-2011 · posted 2011-05-23 · Terminated

Recall details

Recalling firm

Maquet Inc.

Reason for recall

Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.

Action taken

Maquet sent an Urgent Medical Device Corrective Action letter dated 4/15/2011, along with a Action Response Form, via Federal Express to their three customers informing them the incorrect cover sheets were installed with some of the affected "MAGNUS 1180.16F0 carbon-fibre table tops." The firm will have a Service Technician contact you to service the OR table, and will be exchanging the cover sheet free of charge. To the customers, please follow the instructions on the response form. At this time there have been no reports that injury has occurred. If you have additional questions, please contact yur local MAQUET Customer Service at 1-888-627-8383

Root cause

Device Design

Status

Terminated

Product code

KXJ

Quantity affected

3

Distribution

LA, MO, VA

Date initiated

2011-04-15

Date posted

2011-05-23

Date terminated

2013-08-21

Location

Wayne, NJ