ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapist v4.1 system with the LANTIS OIS. The Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-2789-2011 · Posted 2011-07-11
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-25
Date Terminated2012-03-01
Product Quantity45 customers with affected configuration in US, 37 customers ROW.
Reason for Recall
Potential safety issue of possible data loss for the transfer of the same patients treatment data between the LANTIS OIS and the RTT v2.x software and the RT Therapist version 4.1 system
Firm Action
Siemens Customers Service group began providing Update Instructions and installing the software update on affected machines beginning May 25, 2011. A customer information letter was also provided.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA including distribution to LA, CA, PA, MA, NE, NJ, DE, WI, NC, NY, WI, MD, FL, KY and to Poland, Netherlands, Ireland, G=Belgium, Germany, New Zealand, P.R. China, Saudi Arabia, Australia, Malaysia, Egypt, Canada, and Spain.
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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