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. |
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