FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
- Recall number
- Z-2097-2015
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
- Status
- Terminated
- Initiated
- 2015-06-10
- Posted
- 2015-07-17
- Terminated
- 2016-04-18
- Reason
- There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a collision.
- Root cause
- Device Design
- Action
- Maquet sent a field correction letter dated June 8, 2015, via Fed Ex. Customers are advised of the issue with the device and provided instructions. Questions or additional information can be obtained from the local Maquet representative or Maquet Technical Support at 1-888-627-8383 (option 3 followed by option 1) Monday through Friday between the hours of 8:00 am and 6:00 pm EST.
- Quantity
- 12 units
- Distribution
- Worldwide Distribution - US Nationwide Distribution and to the countries of : France, Australia, Belgium, Brazil, Switzerland, Chile, China, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Japan, Kuwait, Kazakhstan, Mexico, Netherlands, Norway, Russia, Sweden, Turkey, Taiwan and South Africa.
- Lot, serial or model codes
- SN 00048
- 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