FDA-Device2019-06-19Class II
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.
GE Healthcare, LLC
Hazard
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Sold states
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.
Affected count
825 (38 US and 787 OUS) in total
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1754-2019Don't want to check this manually?
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