FDA-Device2015-07-08Class II
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.
GE Healthcare
Hazard
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
Sold states
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.
Affected count
4,053 (3,804 US; 249 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1966-2015Don't want to check this manually?
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