Company: Iba Dosimetry Gmbh
Date of Enforcement Report:12/18/2013
Class lI:
PRODUCT
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological Recall Number Z-0456-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Iba Dosimetry Gmbh, Schwarzenbruck, DE on 8/20//2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
33 Units
DISTRIBUTION
Nationwide and Internationally
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