GE Healthcare, LLC recalls Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed f

Recalled June 19, 2019 · FDA recall Z-1753-2019 · GE Healthcare

Hazard

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

Units

825 (38 US and 787 OUS) in total

Sold at

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.

Description

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

Product

Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →