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Iba Dosimetry Gmbh recalls COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Recalled November 12, 2014 · FDA recall Z-0168-2015 · Iba Dosimetry
Hazard
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose. · FDA Class II
Units
124 units
Sold at
Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
Description
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
Product
COMPASS, Model No. SW Version 3.1, catalogue 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 →