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.
- Recall Initiated
- January 17, 2013
- Posted
- March 5, 2013
- Terminated
- March 5, 2013
- Recall Number
- Z-0907-2013
- Quantity
- 5 units
- Firm Location
- Concord, CA
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.
Distribution
5 devices, all located outside of the United States in Germany.
Lot / Code Info
All codes/units of ARTISTE model.
Root Cause
Software design
Action Taken
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.