FDA-Device2021-12-01Class II
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
GE Healthcare, LLC
Hazard
The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
Sold states
Worldwide and US Nationwide Distribution
Affected count
105 in total
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0242-2022Don't want to check this manually?
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