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Recall Observatory FDA recall evidence

Device product

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

Z-2097-2015

June 10, 2015

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 71446
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2097-2015

Official wording

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.

Code information: SN 00048

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.