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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 Recall
ARTISTE" syngo RT Therapist (RRT)
see related information
Date Posted March 05, 2013
Recall Status1 Terminated on March 05, 2013
Recall Number Z-0907-2013
Recall Event ID 64214
Premarket Notification
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/
Manufacturer
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord, California 94520-1200
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Christine Dunbar Senior Manager - Regul
925-602-8157
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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