In the agency's Nov 11, 2026 enforcement report · Ongoing
Senographe Pristina
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Senographe Pristina
- Lot codes and dates
- GTIN(s)
0084068211846000840682142052008406821458790019527802274500195278276971001952786619990019527866537900195278914026001989531092811019895305431110195278901764
- GTIN(s)
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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