Device product
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Z-0780-2014
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 67078
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-0780-2014
Official wording
Reason: When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Code information: Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher
Distribution pattern: Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.
Derived failure modes
-
Unknown
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.