Recall Z-0862-2024 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Medical Systems, SCS
Senographe Pristina
| Date | Feb 8, 2024 (initiated Dec 26, 2023) |
| Status | Open, Classified |
| Reason | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE HealthCare will, without charge, remedy the defect or bring the product into compliance. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 180 units (60 US; 120 OUS) |
| Distribution | Us Nationwide-Worldwide Distribution |
| FDA record | Open on fda.gov |