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

FDA device recall Z-2097-2015 · posted 2015-07-17 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

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.

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.

Root cause

Device Design

Status

Terminated

Product code

FQO

Quantity affected

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,

Date initiated

2015-06-10

Date posted

2015-07-17

Date terminated

2016-04-18

Location

Wayne, NJ