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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
GE Healthcare Definium 5000		see related information
Date Posted February 27, 2013
Recall Number Z-0704-2013
Product GE Healthcare Definium 5000/5220493-2 X-Ray System
Code Information Definium Model 5000/5220493-2
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
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.
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
 
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