FDA-Device2012-06-20Class II
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
General Electric Med Systems LLC
Hazard
An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath
Sold states
Worldwide Distribution.
Affected count
3,796 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1789-2012Don't want to check this manually?
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