Device Recall Precedence

  • Model / Serial
    Catalog number 882351; Model numbers (3/8): 4535-602-53551,2169-3002A;  Serial numbers: 3000039 KP06090002 KP05070002 3000034 3000038 3000027  Model numbers (5/8); 4535-602-53561,2169-3003A. Serial number: KP06080001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 || Philips Medical Systems || An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model #: 882350; Serial #s: 300072, 3000068, 3000071, 3000073, 3000074, 3000075, 3000076, 3000077, 3000078, 3000079, 3000081, 3000082, 3000083, 3000084, 3000085, 3000086, 3000087, 3000088, 3000089, 3000090, 3000091, 3000092, 3000093, 3000094, 3000095, 3000096, 3000097, 3000098, 3000099, 3000100, 3000101, 3000102, 3000103, 3000104, 3000105 & 3000106.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
  • Model / Serial
    Model #: Slice882351; Serial #: 3000046
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    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
  • Model / Serial
    Precedence 6 Model # 882351 Serial Numbers :  KP05100002 KP06040012 KP05040006 KP05080007 KP05110003 KP0510008 30008 KP06110019 K06110017 6080522 30007060027 3000034 3000032 30007060029 3000006 KP06020011 KP06050013 KP06080008 KP05110004 KP06110018 30007040026 KP06070015 30007060028 3000033 30007030025 3000031 3000035 3000040 3000041 30058 3000049 3000054 3000039 3000038 3000042 3000093 3000044 3000036 3000043 3000047 KP06070048 3000074 3000059 3000055 340090 3000057 3000058 3000053 3000050 3000056 3000052 3000061 3000051 3000045 3000048 3000069 3000066 3000078 3000060 3000064 3000068 3000065 30007070030 3000071 3000063 3000067 3000062 300072 3000095 3000073 3000085 30007080011 30007040024 3000102 3000075 3000076 7021 3000092 3000098 3000087 3000077 3000082 3000080 3000081 3000088 3000079 3000083 3000084 3000089 3000091 3000096 3000097 3000100 3000086 3000090 3000099 3000094 3000104 3000101 3000103 3000105 3000106 3000037 3000708005 30006120020 30007020023
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Precedence 16 Model # 882350 || 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
  • Model / Serial
    Serial Numbers: 3000037, 3000048
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    International distribution only: Mexico and Saudi Arabia.
  • Product Description
    Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, || Model Number: 4535 602 50851, Catalog Number: 882350, || Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH || Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
  • Manufacturer
One more