FDA recall, , Moderate risk
GE Senographe Pristina Mammography Systems
GE Senographe Pristina Mammography Systems may show collimator blades or open more than expected in 3D+2D manual mode.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems, LLC, of Waukesha, Wisconsin, has begun a voluntary recall, requested by the FDA, of certain Senographe Pristina and Senographe Pristina 3D systems. The agency became aware of a nonconformance in certain Senographe Pristina VIA systems. In cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, the collimator blades might be visible in the image.
The company began the recall on August 28, 2026, and the FDA added it to the Enforcement Report and classified it on November 4, 2026. The systems were distributed in the USA and OUS. For people who have these systems, the recall notice states the potential visibility of collimator blades in images.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Senographe Pristina
- UDI-DI
- 00840682118460
- 00840682142052
- 00840682145879
- 00195278022745
- 00195278276971
- 00195278661999
- 00195278665379
- 00195278914026
- 00198953109281
- 10198953054311
- 10195278901764
Senographe Pristina 3D
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
USA and outside the U.S.
- Recalled by
- GE Medical Systems, LLCWaukesha, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100070
- Recall numbers
- Z-0326-2027 to Z-0328-2027
- Recall type
- Voluntary: FDA requested
All recalls from GE Medical Systems, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
GE Medical Systems began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
