Device Recall Philips Ingenuity CT

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

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