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GE Healthcare recalls GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: T
Recalled March 25, 2015 · FDA recall Z-1279-2015 · GE Healthcare
Hazard
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 · FDA Class II
Units
472 (127 units US, 345 units OUS)
Sold at
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,PORTUGAL, POLAND, PERU, NORWAY, NETHERLANDS, MEXICO, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, INDIA, GREECE, GERMANY, FRANCE, ESTONIA, DENMARK, CZECH REPUBLIC, CYPRUS, COLOMBIA, CHINA, CANDA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA.
Description
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
Product
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.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →