GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview ...
FDA Recall #Z-1789-2012 — Class II — May 31, 2006
Product Description
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.
Reason for Recall
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
Recalling Firm
General Electric Med Systems LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,796 units
Distribution
Worldwide Distribution.
Code Information
All serial numbers
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated