Recall – Software Treatment Planning System bug leads to dose invalidated

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 1/1/2020
Class II

PRODUCT

RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 – Product 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.

  • Recall Number: Z-0736-2020

REASON

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 11/18/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

956 Devices/Licences

DISTRIBUTION

U.S. Nationwide

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