FDA-Device2015-01-21Class II
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
GE Healthcare
Hazard
Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
Sold states
US: FL, WA, IL, UT, NY, CA. OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
Affected count
13 (7 US, 6 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2015Don't want to check this manually?
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