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

Recall Z-0907-2013 — SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.

U.S. FDA — Device Enforcement · United States · 2013-01-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0907-2013
Date of alert
2013-01-17
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: Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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