Recall – Software treatment planning system erroneously labels dose

Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report: 5/26/2021
Class II

PRODUCT

RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system.

Recall Number: Z-1597-2021

REASON

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

RECALLING FIRM/MANUFACTURER

RAYSEARCH LABORATORIES AB on 2/22/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

116 units

DISTRIBUTION

U.S. Nationwide

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