Devices

Device Recall GEMINI PET/CT diagnostic imaging systems

  • Model / Serial
    Catalog Numbers: 882390 and 882410; Model Numbers: 4535 679 75691 and 4535 679 71891; and Serial Numbers: 4190 and 4191.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea.
  • Product Description
    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA

One device with a similar name

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Device Recall GEMINI PET/CT diagnostic imaging systems
  • Model / Serial
    Catalog Numbers: 882470, 882471, and 882473; Model Numbers: 4535 679 83931 , 4525 679 94741, and 4535 674 41711; and Serial Numbers: 7096, 7139, 7144, 7145, 7146, 7148, 7149, 7150, and 7151.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea.
  • Product Description
    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc