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GE Healthcare recalls GE Healthcare Precision RXi Digital system
Recalled July 29, 2015 · FDA recall Z-2122-2015 · GE Healthcare
Hazard
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems. · FDA Class II
Units
788 (701 US; 87 OUS)
Sold at
Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
Description
A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.
Product
GE Healthcare Precision RXi Digital system
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →