ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-1092-2012 · Posted 2012-02-23
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-01-22
Date Terminated2012-11-07
Product Quantity182 active devices
Reason for Recall
Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
Firm Action
Siemens customers with active devices will receive the software update through the distribution of the "Update Instructions" with a release date of January 22, 2012. The software update will be delivered and installed by a qualified Field Service Engineer utilizing a SW kit and instruction distributed by the Update instruction. Consignee notification of the Update Instructions will be delivered by Customer Service or by certified mail.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA, including the states of WI, UT, PA, TN, OH, LA, DE, MI, NJ, FL, NE, WV, MO and the countries of Germany, Spain, Poland, Australia, Malaysia, New Zealand, India, Republic of Korea, Canada, Italy, Egypt, Philippines, France, Belgium, Saudi Arabia, South Africa, Norway, Turkey , Hungary, Russian Federation, P.R. China, Lebanon, Iran, and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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