Device product
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Z-2180-2014
Product summary
- Event
- Event 68634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56
- Official record key
device-enforcement:Z-2180-2014
Official wording
Reason: Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.
Code information: Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604 Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only: 10010 10046 10586 No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S.
Distribution pattern: UT, WI, NY
Derived failure modes
-
Device software or design
software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause