Product Wiki · Recalls · U.S. FDA — Device Enforcement

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological — recall Z-0456-2014

U.S. FDA — Device Enforcement · Germany · 2013-08-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0456-2014
Date of alert
2013-08-20
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Iba Dosimetry Gmbh
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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