Device recall
Senographe Pristina 3D
- Recall number
- Z-0328-2027
- Event id
- 100070
- Status
- Open, Classified
- FDA classification
- Class III
- Recalling firm
- GE Medical Systems, LLC
- Posted
- Nov 4, 2026
- Initiated
- Aug 28, 2026
- Product code
- OTE
- Device type
- Digital Breast Tomosynthesis
- 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
- Code info
- N/A
- Distribution
- USA and OUS.
- Location
- Waukesha, WI