FDA-Device2015-05-13Class II
GE Discovery MR950 MRI system
GE Healthcare
Hazard
The alignment lasers are missing the labels required by radiation safety regulations.
Sold states
US Distribution to the state of CA., and Internationally to Italy and Japan.
Affected count
5 units (2 in US)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Discovery MR950 MRI system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2015Don't want to check this manually?
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