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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 11, 2012
Recall Status1 Terminated on March 28, 2013
Recall Number Z-1988-2012
Recall Event ID 62107
Premarket Notification
510(K) Numbers
K012009  K033326  K060937 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Code Information Model number 881001; Serial numbers: 81172, 79937, 85083, 81097, 85145, 79916, 81132, 85011, 82020, 85007, 85006, 85081, 81028, 80914, 82004, 85041, 81180, 82016, 30019, 80910, 81133, 81098, 81169, 79940, 80980, 82036, 82007, 85084, 85085, 82039, 81127, 81165, 30003, 80818, 30007, 85042, 81184, 82021, 82030, 82023, 82051, 82026, 82024, 82028, 82050, 82025, 82029, 82027, 30018, 79933, 82015, 85089, 30036, 81183, 82037, 80425, 81157, 85025, 82011, 81174, 80965, 80966, 81026, 35006, 82009, 81013, 82003 & 80891.
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
Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Philips representative or the Customer Care Solutions Center at 1-800-722-9377, option 5, for questions regarding this recall.
Quantity in Commerce 96
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France.
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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