FDA-Device2012-07-25Class II
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
GE Healthcare, LLC
Hazard
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Sold states
Worldwide Distribution (USA) nationwide
Affected count
254 units have been shipped to/installed in the U.S.
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2012Don't want to check this manually?
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