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Recall Observatory FDA recall evidence

Device product

Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.

Z-2075-2014

May 15, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 68395
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-2075-2014

Official wording

Reason: An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI

Code information: material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272

Distribution pattern: US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI