Z-2238-2011

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

Name: Z-2238-2011 Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for...
Creator: Maquet Inc.
Published: 2011-04-15
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-04-15 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top... on 2011-04-15. The reason FDA records is "Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2238-2011
Status: Terminated
Initiated: 2011-04-15
Posted: 2011-05-23
Terminated: 2013-08-21
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.
Product code: KXJ Table, Radiologic
Reason for recall: Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 3
Distribution: LA, MO, VA
Product codes and lots: Article 1180.16F0, serial number 00004 Article 1180.16F2, serial number 00001 and 00002

Product code KXJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)