FDA-Device2013-10-23Class II
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
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
28 (4 US & 24OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0024-2014Don't want to check this manually?
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