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Philips Medical Systems (Cleveland) Inc recalls Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT
Recalled April 24, 2013 · FDA recall Z-1102-2013 · Philips Medical Systems (Cleveland)
Hazard
Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor conti · FDA Class II
Units
313 units
Sold at
Worldwide Distribution - (USA) Nationwide Distribution including the states of AL, AR, AZ, CA, FL, GA, IA, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI & WV. and the countries of Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Monaco, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom
Description
Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor conti
Product
Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →