RAYSEARCH LABORATORIES AB recalls RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) m…

Recall date

May 26, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2426-2020

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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