FDAFDA · Food and drugs·Recall number Z-2073-2012
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.
Published August 1, 2012 · Recall initiated: June 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential safety issue when using the IMMEDIATE RESUMPTION feature 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Worldwide Distribution, including the state of Florida (USA) and the countries of Germany, India, Poland, Thailand, and the Republic of Korea.
- Lot
- ARTISTE, Part #: 08139789, ONCOR Avant Garde, Part #: 05863472, ONCOR Impression Plus, Part #: 05857912, ONCOR Expression, Part #: 07360717
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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