Company:Iba Dosimetry Gmbh.
Date of Enforcement Report: 3/4/2015
Class lI:
PRODUCT
COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological. Recall Number Z-1212-2015
REASON
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
RECALLING FIRM/MANUFACTURER
Iba Dosimetry Gmbh, Schwarzenbruck, DE on 2/2/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
DISTRIBUTION
Worldwide
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