Ge Healthcare GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Brand
Ge Healthcare
Lot Codes / Batch Numbers
All associated serial numbers
Products Sold
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Ge Healthcare is recalling GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy. due to A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
Recommended Action
Per FDA guidance
An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026