FDAApril 7, 2021device

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

What to do

FDA enforcement status: Terminated

Brands named

raysearch laboratories abraysearchraysearch laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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