Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 2/4/2015
Class lI:
PRODUCT
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and 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
Recall Number Z-1013-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 1/2/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
3
DISTRIBUTION
UT, WI, NY
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