FDA-Device2014-01-29Class II
SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.
Siemens Medical Solutions USA, Inc
Hazard
In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.
Sold states
Class II Recall - Worldwide Distribution - US Distribution including the states of California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky and Michigan., and the countries of Bulgaria, Germany, Belarus, Russian Fed., P.R. China, India, Republic Korea, Germany, Costa Rica, Argentina, Portugal, Greece, Bulgaria, Vietnam, Hungary, Italy, Palestinian Ter, Hungary, Jordan, Egypt Poland, Greece, Curacao, St Eus, Malaysia, Egypt, Malaysia, South Africa Turkey, Thailand, Qatar and Iraq.
Affected count
65 active devices
Manufactured in
757 Arnold Dr Ste A, Martinez, CA, United States
Products
SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2014Don't want to check this manually?
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