—#115406

Product

GE Healthcare Definium 5000/5220493-2 X-Ray System

FDA product code: JAC — System, X-Ray, Film Marking, Radiographic
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: Definium Model 5000/5220493-2

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2012-09-26
Posted by FDA: 2013-02-27
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115406. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.