FDA-Device2013-10-23Class II
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
GE Healthcare, LLC
Hazard
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
Sold states
Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
Affected count
380 (52 US & 328 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0023-2014Don't want to check this manually?
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