Device Recall Precedence 6

  • Modèle / numéro de série
    Model #: Slice882351; Serial #: 3000046
  • 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
    Precedence 6 (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

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Precedence 6 Model # 882351 Serial Numbers :  KP06080001 KP06090002 3000027 3000028 747866A0 KP06020006 30007020021 KP06080010 3000030 KP06090012 KP06100013 KP06110015 30007030020 30007010017 30007030021 30007060024 30007070025 30007050023 30007050022 3000029 3000036 3000002 3000040 3000031 3000032 3000033 3000038 3000035 3000034 3000039 H3000037 3000042 3000041 3000043 3000044 3000046 3000045 30007030016 3000003 3000037 6111502 KP06070007 KP06080008
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Precedence 6 Model # 882351 || Product Usage: || Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
  • Manufacturer