FDA-Device2015-05-06Class II
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
GE Healthcare
Hazard
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Sold states
US Distribution to the states of: AZ, FL, GA, MO and WI.
Affected count
6 units in US
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2015Don't want to check this manually?
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