Device Recall Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc.,

  • Model / Serial
    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, 81172, 81173, 81174, 81175, 81178, 81179, 81182, 81183, 81184, 81187, 81189, 81190, 81192, 81194, 81196, 81200, 82001, 82002, 82003, 82004, 82006, 82007, 82008, 82009, 82010, 82011, 82012, 82013, 82014, 82015, 82016, 82017, 82018, 82019, 82020, 82021, 82022, 82023, 82024, 82025, 82026, 82027, 82028, 82029, 82030, 82031, 82032, 82033, 82034, 82035, 82036, 82037, 82038, 82050, 82051, 82052, 82053, 82054, 82055, 82056, 82057, 82058, 82059, 82060, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82084, 82086, 82087, 82088, 82089, 82090, 82091, 82092, 82095, 82097, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82110, 82112, 82116, 82118, 82120, 82121, 82123, 82125, 82126, 82128, 82129, 82130, 82131, 82132, 82133, 82138, 82142, 82143, 82144, 82146, 82148, 82201, 82202, 82203, 82236, 82238, 82240, 82241, 82250, 82251, 85005, 85006, 85007, 85008, 85009, 85010, 85011, 85014, 85025, 85026, 85027, 85028, 85029, 85031, 85032, 85033, 85040, 85041, 85042, 85043, 85044, 85046, 85047, 85049, 85050, 85066, 85067, 85068, 85069, 85080, 85081, 85082, 85083, 85084, 85086, 85088, 85090, 85096, 85103, 85104, 85105, 85106, 85107, 85108, 85110, 85117, 85141, 85143, 85144, 85145, 85149, 85164, 85165, 85167, 85168, 85169, 85170, 85171, 85172, 85174, 85175, 85176, 85177, 85178, 85179, 85180, 85213, 85214, 85215, 85216, 85217, 85218, 85219, 85238, 85239, 85243, 85244, 85245, 85246, 85247, 85248, 85249, 85250, 85252, 85253, 85254, 85255, 85257, 85260, 85296, 85299, 85300, 85302, 85305, 85306, 85307, 85308, 85309, 85312, 85315, 85316, 85317, 85319, 85320, 85322, 85329, 85330, 85332, 85333, 85334, 85335, 85337, 85338, 85355, 85373, 85475, 95001, 95007, 95008, 95009, 820001, 822002, 822003, 822004, 822005, 822009, 822017, 850004, 850015, 920003 & 950001.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA