Reported Apr 24, 2013 · Terminated

Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT,…

Philips Medical Systems (Cleveland) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • 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.
Lot codes and dates
  • 320 of 320 codes

    • Model #881001
    • Serial #s: 79916
    • 79932
    • 79933
    • 79935
    • 79936
    • 79937
    • 79939
    • 79940
    • 79943
    • 80071
    • 80914
    • 80916
    • 80925
    • 80926
    • 80928
    • 80932
    • 80939
    • 80963
    • 80965
    • 80977
    • 80979
    • 80994
    • 80995
    • 81004
    • 81006
    • 81008
    • 81010
    • 81026
    • 81027
    • 81028
    • 81034
    • 81035
    • 81036
    • 81039
    • 81063
    • 81065
    • 81076
    • 81079
    • 81081
    • 81085
    • 81089
    • 81097
    • 81098
    • 81108
    • 81110
    • 81117
    • 81119
    • 81127
    • 81130
    • 81132
    • 81133
    • 81150
    • 81153
    • 81154
    • 81160
    • 81161
    • 81163
    • 81165
    • 81169
Amount recalled
313 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2013 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.