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U.S. Department of Health and Human Services

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.
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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