GE Healthcare recalls GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The…

Recall date

March 5, 2015

Source

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

Recall number

Z-1279-2015

FDA classification

Class II

Brand / firm

GE Healthcare

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NY, NC, OK, PA, PR, SD, TN, TX, VA, WA, WV, WI. and the countries of URUGUAY, UNITED KINGDOM,UKRAINE, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVAKIA, RUSSIA,PORTUG…

Why it was recalled

GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date

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 Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.