FDA-Device2013-04-17Class II
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
GE Healthcare, LLC
Hazard
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
Sold states
Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.
Affected count
2180
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2013Don't want to check this manually?
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