Device product
RayStation Product Usage: 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-0380-2018
Product summary
- Event
- Event 78900
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117 units
- Official record key
device-enforcement:Z-0380-2018
Official wording
Reason: For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Code information: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7
Distribution pattern: US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
Derived failure modes
-
Unknown
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.