Siemens Medical Solutions USA, Inc recalls Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator syst…

Recall date

January 2, 2015

Source

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

Recall number

Z-1013-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

UT, WI, NY

Why it was recalled

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.

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

What was recalled

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