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U.S. Department of Health and Human Services

Class 2 Device Recall Definium 8000

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  Class 2 Device Recall Definium 8000 see related information
Date Initiated by Firm May 31, 2006
Date Posted June 08, 2012
Recall Status1 Terminated 3 on July 31, 2012
Recall Number Z-1789-2012
Recall Event ID 37654
510(K)Number K012389  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product 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.
Code Information All serial numbers
Recalling Firm/
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
Device Design
Action GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.
Quantity in Commerce 3,796 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.