FDA-Device2016-05-11Class II
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
GE Medical Systems, LLC
Hazard
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Sold states
Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.
Affected count
26 (US = 4;OUS = 22)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE, Revolution CT. The system is 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-1589-2016Don't want to check this manually?
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