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U.S. Department of Health and Human Services

Class 2 Device Recall syngo RT Therapist and syngo RT Therapist

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  Class 2 Device Recall syngo RT Therapist and syngo RT Therapist see related information
Date Initiated by Firm November 02, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on March 21, 2012
Recall Number Z-0462-2012
Recall Event ID 60461
510(K)Number K103606  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information Part number 08162815 - syngo RT Therapist Part number 08168754 - syngo RT Therapist Connect/MOSAIQ OIS. Part number 10652131 - syngo RT Oncologist Part number 10658604 - syngo Suite for Oncology System.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 85 affected customers RT Therapa[ist, 62 customers Oncology
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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