Maquet Cardiovascular Us Sales, Llc recalls Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH…

Recall date

June 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2097-2015

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

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, Taiw…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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