—#188000

Product

Revolution CT

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133705, K163213, K191777
Affected lot / code info: 5590000 5590000-6 5590000-2

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide

Timeline

Recall initiated: 2021-03-19
Posted by FDA: 2021-07-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.