Recall Z-2097-2015 ยท FQO Table, Operating-Room, Ac-Powered
Maquet Cardiovascular Us Sales, Llc
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
| Date | Jul 17, 2015 (initiated Jun 10, 2015) |
| Status | Terminated |
| 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, Taiwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.