Device product
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
Z-2785-2015
Product summary
- Event
- Event 71477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 devices
- Official record key
device-enforcement:Z-2785-2015
Official wording
Reason: An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
Code information: software build numbers are 4.7.0.15 or 4.7.1.10
Distribution pattern: Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.
Derived failure modes
-
Unknown
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images