Senographe PristinaRecalls & reported problems across all models
Ge Medical Systems · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Senographe Pristina model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 8 models of Senographe Pristina by Ge Medical Systems in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Senographe Pristina recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 24, 2025Class IIOpen, Classified
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).
Z-0875-2026 · Root cause: Radiation Control for Health and Safety Act · names 8 of these models · Recall details · FDA record ↗
- Dec 26, 2023Class IIOpen, Classified
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Z-0862-2024 · Root cause: Radiation Control for Health and Safety Act · names 7 of these models · Recall details · FDA record ↗
Senographe Pristina models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Senographe Pristina EKB4Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB6Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina NAY2Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina NAY3Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB1Full field digital,system,x-ray,mammographic2 recalls0 reports
- Senographe Pristina EKB2Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina EKB3Full field digital, system, x-ray, mammographic2 recalls0 reports
- Senographe Pristina MBE2Full Field Digital, System, X-Ray, Mammographic1 recall0 reports
Other Ge Medical Systems products
All Ge Medical Systems devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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