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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COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological — Recall Details · AllClear