medical Class II Updated 2019-06-19

GE Healthcare, LLC recalls Precision 500D The Precision 500D R&F X-ray System is in

Recalled Product

Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.

Hazard / Issue

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.
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