Recall Z-1900-2021 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
| Date | Jun 14, 2021 |
| Status | Open, Classified |
| Reason | Improperly loaded software options may result in additional X -ray radiation exposure to the patient. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare will send an Important Electronic Product Radiation Warning letter to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take to prevent this issue. |
| Quantity | 3665 |
| Distribution | 3,665 (US = 956; OUS = 2,709) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131576 | OPTIMA CT660 Ge Medical Systems, LLC, Aug 30, 2013 |