Senographe Pristina recallZ-0875-2026 · GE Medical Systems, LLC · initiated Oct 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label.
Recall details
- Recall number
- Z-0875-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 24, 2025
- Posted by the FDA
- Dec 9, 2025
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Product code
- MUE
- FDA submissions
- K162268, K173576, K182951
- Distribution
- U.S. and OUS.
Product description
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Code information (models, lots, serial numbers)
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- Senographe Pristina EKB4Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB6Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina NAY2Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina NAY3Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB1Ge Medical Systems · Full field digital,system,x-ray,mammographic2 recalls0 reports
- Senographe Pristina EKB2Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB3Ge Medical Systems · Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina MBE2Ge Medical Systems · Full Field Digital, System, X-Ray, Mammographic1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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