Device product
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: 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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Z-2290-2018
Product summary
- Event
- Event 80252
- Status
- Terminated
- Classification
- Class II
- Quantity
- 728
- Official record key
device-enforcement:Z-2290-2018
Official wording
Reason: The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Code information: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 and 7.0.0.19
Distribution pattern: US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.
Derived failure modes
-
Unknown
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.