FDA-Device2012-09-19Class II
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare, LLC
Hazard
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Sold states
Worldwide Distribution -- USA (nationwide) Distribution
Affected count
254 total in the US
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2256-2012Don't want to check this manually?
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