GE Healthcare, LLC Revolution CT Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revolution CT
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
5590000 5590000-6 5590000-2
Products Sold
5590000 5590000-6 5590000-2
GE Healthcare, LLC is recalling Revolution CT due to GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Recommended Action
Per FDA guidance
GE Healthcare will perform an initial site assessment and replace the collimator, if needed. This will be followed by bi-weekly remote monitoring of the system s log file. Finally, GE Healthcare will install a currently under development software patch, added to the daily fast calibration to automatically and reliably detect this failure should it occur. All of these actions will be performed at no cost to the customer. For questions call 262-544-3217.
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