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Recall Observatory FDA recall evidence

Device product

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

Z-1013-2015

January 02, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 70200
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-1013-2015

Official wording

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.

Code information: model # 08162815, serial #s 10010, 10046, 10586

Distribution pattern: UT, WI, NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.