—#109862

Product

Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009, K033326, K060937
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-05-23
Posted by FDA: 2012-07-11
Terminated: 2013-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109862. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.