RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system

Recall date

February 20, 2020

Source

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

Recall number

Z-1466-2020

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

The products were distributed to the following US states: TN

Why it was recalled

There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

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/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system