Device Recall Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system

  • Model / Serial
    Site Numbers:  6931, 6934, 25834, 25901, 26140, 38086, 38195, 38196, 38279, 38500, 38539, 41111, 44282, 44656, 44657, 45070, 50230, 64158, 73286, 80306, 82503, 82630, 82646, 84939, 86395, 100727, 101142, 101555, 102034, 102169, 102590, 102591, 103421, 104104, 104810, 520185, 557985, 558101, and 558174.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY.
  • Product Description
    Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. || The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/universal system, general R/F, Fluoroscopy, Radiography, and Angiography can be performed along with pediatric examinations and some more specialized interventional applications.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA