FDA-Device2015-03-25Class II
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.
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
Sold states
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.
Affected count
472 (127 units US, 345 units OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1279-2015Don't want to check this manually?
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