Device Recall BrightView Gamma Camera Radius Drive

  • Model / Serial
    All units: 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 || Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Phillips Nuclear Medicine, 540 Alder Dr Bldg 4, Milpitas CA 95035-7443
  • Manufacturer Parent Company (2017)
  • Source
    USFDA