Z-1045-2016Class II

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

Name: Z-1045-2016 Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2016-01-07
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2016-01-07 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after... on 2016-01-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1045-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-07
Posted: 2016-03-03
Terminated: 2017-05-25
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.
Product code: FQO Table, Operating-Room, Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: Catalog Number 1180.19F0; Serial numbers 00003 and 00004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1045-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03

Product code FQO

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)