Devices

Device Recall Ingenuity CT

  • Modèle / numéro de série
    Model #: 728326; Serial #s: 30003, 30005, 30006, 30007, 30008, 30009, 30011, 30012, 30013, 30014, 30015, 30018, 30019, 30022, 30028, 300003, 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300024, 300025, 300027, 300028, 300029, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300046, 300047, 300048, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 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, 300116, 300117, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300135, 300136, 300139, 300140, 300142, 300143, 300144, 300145, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 310058 & 30004-1.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Description du dispositif
    Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

Fabricant

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

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall Ingenuity CT
  • Modèle / numéro de série
    System Code #, 728326, Serial #, 300130.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in China.
  • Description du dispositif
    Ingenuity CT. || 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.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Ingenuity CT system
  • Modèle / numéro de série
    Model #728326, Serial Numbers: 300003, 300004, and 300005.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.
  • Description du dispositif
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Ingenuity CT System
  • Modèle / numéro de série
    The following Serial Numbers of this device are subject to recall: Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the states of: LA, NY, OH, WV and the foreign countries of: Australia, Germany, Korea, India, Malaysiaa and New Zealand.
  • Description du dispositif
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. || Product Usage: || The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall InGenuity CT System
  • Modèle / numéro de série
    The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.
  • Description du dispositif
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. || Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc