syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update, the Oncologist will match the RTT version 4.2.108. The intended use of the Siemens branded Artiste, Oncor and Primus family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-0462-2012 · Posted 2012-01-11
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-11-02
Date Terminated2012-03-21
Product Quantity85 affected customers RT Therapa[ist, 62 customers Oncology
Reason for Recall
The software release will bring current Installed Base system to the forward production version. It is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple performance defects.
Firm Action
Siemens sent Customer Information letters and Update Instructions TH024/11/S for the installation of software release 4.2.108 beginning on November 2, 2011 to all affected consignees. Sites with active devices for the Oncology system were sent the current Update Instructions TH014/11/S for the installation of software release 4.2.108 and Customer Information letter beginning November 22, 2011.
Consignees were asked to include the Customer Information in their syngo RT Oncologist System Owner Manual chapter "Safety Advisory Letters" where it should remain.
For questions regarding this recall call 925-602-8157.
Root Cause
Software design
Distribution Pattern
Worlwide Distribution - USA (nationwide) including UT, OH, TN, FL, WI, IN, KY, CA, PA, SD, NY and the countries of India, Germany, United Kingdom, Australia, Poland, Japan, Croatia, India, Columbia, Belgium, Puerto Rico, China, Sweden, South Africa and Czech Republic.
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.