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Recall Observatory FDA recall evidence

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

July 17, 2017

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
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

    reason.no_named_rule · v1.0.0

    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.