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Iba Dosimetry Gmbh recalls COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Recalled March 4, 2015 · FDA recall Z-1212-2015 · Iba Dosimetry
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. · FDA Class II
Units
124 units
Sold at
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, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
Description
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.
Product
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Manufacturer(s)
Iba Dosimetry Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →