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RAYSEARCH LABORATORIES AB recalls RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B incl
Recalled May 26, 2021 · FDA recall Z-1598-2021 · RAYSEARCH LABORATORIES AB
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. · FDA Class II
Units
N/A
Sold at
Domestic: TN
Description
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.
Product
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →