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RAYSEARCH LABORATORIES AB recalls RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) mo
Recalled July 1, 2020 · FDA recall Z-2426-2020 · RAYSEARCH LABORATORIES AB
Hazard
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat. · FDA Class II
Units
12
Sold at
Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.
Description
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Product
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Manufacturer(s)
RAYSEARCH LABORATORIES AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →