FDA-Device2019-01-16Class II

Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

GE Healthcare, LLC
Hazard

Possible incorrect software version loaded.

Sold states
Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mauritania, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam and Zambia
Affected count
3,849
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2019

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