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Philips Medical Systems (Cleveland) Inc recalls Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server t
Recalled July 18, 2012 · FDA recall Z-2000-2012 · Philips Medical Systems (Cleveland)
Hazard
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. · FDA Class II
Units
44
Sold at
Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Switzerland.
Description
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.
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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →