RAYSEARCH LABORATORIES AB recalls RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation…

Recall date

November 12, 2018

Source

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

Recall number

Z-0679-2019

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI

Why it was recalled

Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.

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 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A