Company:GE Healthcare, LLC.
Date of Enforcement Report 2/6/2013
Class ll:
PRODUCT
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Recall Number Z-0754-2013
REASON
It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated. A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure. If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI 5/24/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
65
DISTRIBUTION
Nationwide and Internationally
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