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Recall Observatory FDA recall evidence

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

June 17, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.device_software_design · v1.0.0

    software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause