FDA-Device2020-12-30Class II
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
GE Healthcare, LLC
Hazard
A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Sold states
Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
Affected count
3 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2021Don't want to check this manually?
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