FDAFebruary 11, 2022device

RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayStation 6/RayPlan 2 Service P...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

What to do

FDA enforcement status: Ongoing

Brands named

raysearch americaraysearch

UPCs

073500020100200735000201001307350002010082073500020100750735000201024207350002010068073500020101120735000201013607350002010129073500020102040735000201023507350002010174

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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