Recall Z-0703-2013 ยท JAC System, X-Ray, Film Marking, Radiographic
GE Healthcare, LLC
GE Healthcare Definium 5000 / 5220493 X-Ray System
| Date | Feb 27, 2013 (initiated Sep 26, 2012) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 312 installed in US |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.