Z-2097-2015Class II

Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System...

Name: Z-2097-2015 Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-06-10
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-06-10 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co on 2015-06-10. FDA classified it as Class II and gives the reason as "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...". 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-2097-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-10
Posted: 2015-07-17
Terminated: 2016-04-18
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.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: SN 00048

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2097-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2097-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

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)