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U.S. Department of Health and Human Services

Class 2 Device Recall Intellispace Portal

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 Class 2 Recall
Intellispace Portal
see related information
Date Posted July 12, 2012
Recall Status1 Terminated on March 28, 2013
Recall Number Z-2000-2012
Recall Event ID 62128
Premarket Notification
510(K) Numbers
K012009  K033326  K060937 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
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.
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact Kumudini J. Carter
440-483-7000
Manufacturer Reason
for Recall
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 Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare sent an Urgent-Medical Device Correction letter dated May 23, 2012, via certified mail to each consignee. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. The letter informed affected customers that a Philips Service Engineer will contact them for implementation of the software update on the affected systems free of charge. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).
Quantity in Commerce 44
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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