FDAFebruary 2, 2015device
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
What to do
FDA enforcement status: Terminated
Brands named
iba dosimetryiba
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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