FDA-Device2015-02-04Class II

Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer

Siemens Medical Solutions USA, Inc
Hazard

Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.

Sold states
UT, WI, NY
Affected count
3
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is 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-1013-2015

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