FDA (Devices) recall action 71574
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk to patients or operators.
GE Healthcare is recalling Precision RXi 23A/32A Analog Systems because a monitor suspension failure could cause a monitor to fall and injure a patient or operator.
GE Healthcare is recalling Precision 500D and related fluoroscopic systems because monitor suspensions may fail, posing a risk of injury to patients or operators.
GE Healthcare is recalling Precision MPi fluoroscopic imaging systems because a monitor fell from its suspension, posing a risk of injury to patients or operators.