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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 8000see related information
Date Initiated by FirmMay 31, 2006
Date PostedJune 08, 2012
Recall Status1 Terminated 3 on July 31, 2012
Recall NumberZ-1789-2012
Recall Event ID 37654
510(K)NumberK012389 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductGE 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/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-312-7700
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
ActionGE 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 Commerce3,796 units
DistributionWorldwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQB
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