Iba Dosimetry Gmbh recalls COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

Recall date

February 2, 2015

Source

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

Recall number

Z-1212-2015

FDA classification

Class II

Brand / firm

Iba Dosimetry Gmbh

Sold / distributed

Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Phil…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological