ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.
FDA Recall Z-3003-2011 · Posted 2011-08-11
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-06-03
Date Terminated2012-02-17
Product Quantity223 active devices
Reason for Recall
A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.
Firm Action
Siemens sent an "Urgent: Medical Device Correction/ Customer Safety Advisory Notice" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should remain.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and 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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