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

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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

제조사

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
  • Source
    USFDA