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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
  • Source
    USFDA