FDA-Device2021-02-24Class II
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
GE Healthcare, LLC
Hazard
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
Sold states
Worldwide - US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NV, NY, NH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV; In the countries of Algeria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Denmark, Estonia, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam.
Affected count
96 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1129-2021Don't want to check this manually?
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