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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Definium 5000

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 Class 2 Recall
GE Healthcare Definium 5000
see related information
Date Posted February 27, 2013
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0703-2013
Recall Event ID 64134
Product Classification System, X-Ray, Film Marking, Radiographic - Product Code JAC
Product GE Healthcare Definium 5000 / 5220493 X-Ray System
Code Information Definium Model 5000/5220493
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. A GE Healthcare Service Representative will update the software on the system to address the issue. Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.
Quantity in Commerce 312 installed in US
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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