Date Initiated by Firm | January 17, 2013 |
Date Posted | 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
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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 CA 94520-1200
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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