Recall Z-2004-2021 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Revolution CT
| Date | Jul 8, 2021 (initiated Mar 19, 2021) |
| Status | Completed |
| Reason | 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 | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 197 (US = 40; OUS = 157) |
| Distribution | Worldwide distribution - US Nationwide |
| FDA record | Open on fda.gov |