FDAFDA · Food and drugs·Recall number Z-2075-2014
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.
Published July 23, 2014 · Recall initiated: May 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
- Lot
- material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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