Home / Recalls / Medical Devices
Iba Dosimetry Gmbh recalls iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Recalled December 18, 2013 · FDA recall Z-0456-2014 · Iba Dosimetry
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. · FDA Class II
Units
33 units
Sold at
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.
Description
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.
Product
iba COMPASS SW Version 3.0, 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 →