Device Recall Ingenuity TF

  • Modèle / numéro de série
    Model: 882456; Serial #s: 2003, 2004, 2005, 2006, 2007, 2008, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018.
  • Classification du dispositif
  • 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 TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • 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

5 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
  • Description du dispositif
    Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. || The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
  • Manufacturer
  • Modèle / numéro de série
    M/N 882380; S/N: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.
  • Description du dispositif
    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
  • Manufacturer
  • Modèle / numéro de série
    Ingenuity TF PET/CT (model 882442) SN: 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
  • Description du dispositif
    Ingenuity TF PET/CT (model 882442) running software version 4.0.2 || This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
  • Manufacturer
  • Modèle / numéro de série
    Model #: 882456; Serial #: 2004
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to one customer in Ohio.
  • Description du dispositif
    Ingenuity TF PET/CT. || Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
  • Manufacturer
  • Modèle / numéro de série
    Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed only in Ohio.
  • Description du dispositif
    Ingenuity TF PET/CT. Diagnostic imaging system
  • Manufacturer