Recall Z-0326-2027 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GE Medical Systems, LLC
Senographe Pristina
| Date | Nov 4, 2026 (initiated Aug 28, 2026) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, it can result in the following: the collimator blades might be visible in the image, or the collimator might be open more than expected, and an incorrect collimator filter might be used with respect to the anode track selected This issue could result in a minor additional X-ray dose being delivered to the patient and obvious artifacts in the image (collimator blades). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE HealthCare will send a customer letter dated August 28, 2026, that provides safety instructions for immediate mitigation of the incorrect configuration of the collimator anode track / filter in manual mode during 3D+2D acquisitions. GE HealthCare will correct all affected Senographe Pristina VIA systems by upgrading the software at no cost to the customer. 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. |
| Distribution | USA and OUS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright GE Medical Systems SCS, Mar 24, 2026 |