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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62128
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland) Inc
City Cleveland
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 85068, 79932, 79943, 80911, 82019, 81027, 85049, 85043, 82008, 81119, 81089, 85108, 85026, 85146, 80994, 81021, 81182, 81017, 85067, 81161, 81164, 79936, 85103, 81147, 85110, 85082, 81179, 81035, 85046, 81031, 81129, 81004 & 85104. Class II 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. 44 Z-2000-2012
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