Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1013-2015 — 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

U.S. FDA — Device Enforcement · United States · 2015-01-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1013-2015
Date of alert
2015-01-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08162815
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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