Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. |
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| Recall Number | Z-2073-2012 |
| Classification | Class II |
| Code Info | ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717 |
| Product Distributed Qty | 18 |
| Reason For Recall | Siemens became aware of a potential safety issue when using the "IMMEDIATE RESUMPTION" feature of the syngo RT Therapist 4.2 software after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments; in a very rare scenario, the RT Therapist 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 | 62519 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| City | Concord |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-25 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea. |
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