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Recall Observatory FDA recall evidence

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

November 25, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    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.