Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
This recall has been terminated (originally issued July 17, 2015).
- Recall Initiated
- June 10, 2015
- Posted
- July 17, 2015
- Terminated
- April 18, 2016
- Recall Number
- Z-2097-2015
- Quantity
- 12 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
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 / Code Info
SN 00048
Root Cause
Device Design
Action Taken
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.