FDA-Device2015-09-30Class II
PET Discovery ST 16
GE Healthcare
Hazard
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
Sold states
Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN and UNITED KINGDOM.
Affected count
18
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
PET Discovery ST 16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2803-2015Don't want to check this manually?
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