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U.S. Department of Health and Human Services

Class 2 Device Recall ARTISTE" syngo RT Therapist (RRT)

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  Class 2 Device Recall ARTISTE" syngo RT Therapist (RRT) see related information
Date Initiated by Firm January 17, 2013
Date Posting Updated March 05, 2013
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-0907-2013
Recall Event ID 64214
510(K)Number K121295  
Product Classification Accelerator, linear, medical - Product Code IYE
Product SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
Code Information All codes/units of ARTISTE model.
Recalling Firm/
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar Senior Manager - Regul
Manufacturer Reason
for Recall
Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.
FDA Determined
Cause 2
Software design
Action The firm issued "Urgent Medical Device Correction" letters via mail to all its direct consignees, informing them of the affected product issue and providing instructions on the recall. The firm stated that the release of this UI TH005/13/S to distribute the Customer Safety Advisory Notice began on January 17, 2013.
Quantity in Commerce 5 units
Distribution 5 devices, all located outside of the United States in Germany.
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.