FDA-Device2013-12-18Class II
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Iba Dosimetry Gmbh
Hazard
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.
Sold states
Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
Affected count
33 units
Manufactured in
Bahnhofstr. 5, Schwarzenbruck, Germany
Products
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0456-2014Don't want to check this manually?
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