Ge Medical Systems, Llc: Digital Breast Tomosynthesis
- Recalling firm
- GE Medical Systems, LLC
- Product
- Senographe Pristina 3D
- 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).
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-28
- Status
- Ongoing
- Distribution
- USA and OUS.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2ff6db00-3e6f-40c0-a40b-dd5afef104df