Device Recall Carestream DRXEvolution with Full Featured (FF) Wall Stand (WS)

  • Model / Serial
    Service Code: 7171
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    DRX-Evolution with FF WS || These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Carestream Health, Inc., 1049 Ridge Rd W, Rochester NY 14615-2731
  • Manufacturer Parent Company (2017)
  • Source
    USFDA