GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1754-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 29, 2019

Date Posted: June 19, 2019

Recall Number: Z-1754-2019

Event ID: 82668

Reason for Recall:

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

Status: Terminated

Product Quantity: 825 (38 US and 787 OUS) in total

Code Information:

204787RF1; 205814RF1; 209826500D; 229P500RF2; 410448RF; 417682BRF; 506857P500; 519663PR500; 519685PR500; 561791RM2; 603668C5; 618635RF; 636625SJR1; 718630PRECISION; 770793KP500D2; 810326P500; 850494WF4; 903731PRP500; 985230DCRF4; and AM16KFZ328.

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: AL, CA, CT, FL, GA, HI, IL, LA, MD, MI, MN, MO, NH, NY, OK, PA, TN, and VA; and countries of: Algeria, Argentina, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Cote D'Ivoire, Cyprus, Czech Republic, Egypt , France, French Polynesia, Germany, Greece, Guadeloupe, Guyana, Hungary, Italy, Japan, Korea, Lebanon, Mexico, Morocco, New Caledonia, Norway , Poland, Portugal, Russia, Saudi Arabia,Slovakia, Spain, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated