FDASeptember 22, 2021device

RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5,...

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

The hazard

An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

What to do

FDA enforcement status: Ongoing

Brands named

raysearch laboratories abraysearchraysearch laboratories

UPCs

073500020100200735000201001307350002010082073500020100750735000201024207350002010068073500020101120735000201013607350002010129073500020102040735000201023507350002010174

Recall history

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

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