Company: Iba Dosimetry Gmbh.
Date of Enforcement Report 11/12/2014
Class lI:
PRODUCT
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological. Recall Number Z-0168-2015
REASON
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
RECALLING FIRM/MANUFACTURER
Iba Dosimetry Gmbh, Schwarzenbruck, DE on 9/25/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
124 units
DISTRIBUTION
Nationwide and Internationally
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