Recall Z-0907-2013 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
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.
| Date | Mar 5, 2013 (initiated Jan 17, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 5 units |
| Distribution | 5 devices, all located outside of the United States in Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121295 | ARTISTETM SOLUTION WITH SYS VCIO Siemens Medical Solutions USA, Inc., Jun 27, 2012 |