FDA-Device2012-08-01Class II
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Siemens Medical Solutions USA, Inc
Hazard
Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenario, the RT Therapist will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
Sold states
Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
Affected count
18
Manufactured in
4040 Nelson Ave, Concord, CA, United States
Products
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2073-2012Don't want to check this manually?
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