Company:Philips Medical Systems (Cleveland) Inc .
Date of Enforcement Report 7/18/12
Class ll:
PRODUCT
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network. Z-2000-2012
REASON
In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode “edit contour” tool, the measurements are not recalculated causing discrepancies with the lesion measurements.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH on 5.22.2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
Nationwide and internationally
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