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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description 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
Classification Class II
Code Info All codes/units of ARTISTE model.
Product Distributed Qty 5 units
Reason For Recall 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.

Event Detail

Event Id 64214
Product Type Devices
Status Terminated
Recalling Firm Siemens Medical Solutions USA, Inc
City Concord
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 5 devices, all located outside of the United States in Germany.