Device Recall Precision 500D R&F; System

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Guatemala, Honduras, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Korea (Republic of), Kuwait, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, New Zealand, Panama, Romania, Russia, Saudi Arabia, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
  • Product Description
    GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. || A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. || Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA