FDA-Device2014-11-12Class II
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Iba Dosimetry Gmbh
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.
Sold states
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.
Affected count
124 units
Manufactured in
Bahnhofstr. 5, N/A, Schwarzenbruck, N/A, Germany
Products
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0168-2015Don't want to check this manually?
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