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GE Healthcare recalls Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Recalled April 22, 2015 · FDA recall Z-1441-2015 · GE Healthcare
Hazard
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury. · FDA Class II
Units
797 (3 US, 794 OUS).
Sold at
Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.
Description
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Product
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →