FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: 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.
- Recall number
- Z-1045-2016
- 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.
- Status
- Terminated
- Initiated
- 2016-01-07
- Posted
- 2016-03-03
- Terminated
- 2017-05-25
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Catalog Number 1180.19F0; Serial numbers 00003 and 00004.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQO
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28