Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/13/2013
Class ll:
PRODUCT
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. Recall Number Z-0907-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Concord, CA on 1/17/13. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5
DISTRIBUTION
Germany
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