GE Healthcare, LLC recalls Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your s

Recalled June 19, 2019 · FDA recall Z-1752-2019 · 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

Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.

Manufacturer(s)

GE Healthcare, LLC

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