GE Healthcare recalls GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic…

Recall date

June 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1966-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

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, Ire…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.