Device Recall Philips Ingenuity CT

  • 모델명 / 제조번호(시리얼번호)
    30003, 30004, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 30047, 30048, 30049, 32045, 32083, 32107, 52051, 52060, 52062, 300003, 300004, 300005, 300009, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300022, 300024, 300025, 300027, 300028, 300029, 300030, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300047, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300064, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300083, 300084, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300115, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300133, 300135, 300136, 300137, 300138, 300139, 300140, 300141, 300142, 300143, 300144, 300145, 300146, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300215, 300216, 300217, 300218, 300220, 300221, 300222, 300223, 300224, 300225, 300226, 300227, 300228, 300229, 300230, 300231, 300232, 300233, 310058, 310144, 320205, 333057, 333084, 333128, 336061, 336084, 336121, 30004-1, 52082, 52083, 310251, 310317, 310319, 310321, 310322, 310323, 310324, 310325, 310326, 310327, 310330, 310331, 333137, 333140, 333144, 333146, 333150, 333151, 320259, 320281, 320285, 320288, 320289, 320290, 320291, 320292, 320293, 320295, 320296, 320297, 320299, 320302, 320303, 320305, 320309, 336218, 336219, 336222, 336229, 336234, 336236, 336241, 336246, 336249, 336252, 336256, 336781, 336782, 336783, 336784, 336785, 336786, 336787, 336788, 336789, 336790, 336791, 300219, 52080, 52084, 310019, 310244, 310268, 310298, 310302, 310305, 310306, 310307, 310309, 310310, 310314, 310322, 310334, 310335, 310338, 310339, 310340, 333120, 333126, 333127, 333130, 333131, 333132, 333138, 333139, 333141, 333142, 333143, 333148, 333152, 333153, 333154, 32022, 32171, 320277, 320294, 320300, 320304, 320306, 320308, 320314, 320315, 320316, 320317, 320318, 320319, 320320, 320321, 320322, 320323, 320324, 320325, 320326, 320327, 320328, 320329, 320331, 320332, 320335, 336237, 336238, 336239, 336240, 336242, 336244, 336250, 336251, 336253, 336254, 336255, 336258, 336264, 336266, 600023, 600047, 941192, 941200, 941204 and 941206.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
  • 제품 설명
    Ingenuity CT 728326 || Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
  • Manufacturer
  • 1 Event

제조사

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