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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

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.
Recall Number Z-1789-2012
Classification Class II
Code Info All serial numbers
Product Distributed Qty 3,796 units
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

Event Detail

Event Id 37654
Product Type Devices
Status Completed
Recalling Firm General Electric Med Systems LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2006-05-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution.