GE Healthcare Definium 5000 / 5220493 X-Ray System
Recall
- Recall Number
- Z-0703-2013
- Event Number
- 64134
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- JAC
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- September 26, 2012
- Posted
- February 27, 2013
- Terminated
- December 5, 2013
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
GE Healthcare Definium 5000 / 5220493 X-Ray System
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.
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.
Nationwide Distribution
312 installed in US