FDA-Device2014-08-20Class II

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.

Siemens Medical Solutions USA, Inc
Hazard

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.

Sold states
UT, WI, NY
Affected count
56
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2180-2014

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