Recall archive / FDA device enforcement
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography — FDA record Z-0875-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Reason
- 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).
- Classification
- Class II
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0875-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. and OUS.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 17, 2025
- Recall initiation date
- Oct 24, 2025
- Center classification date
- Dec 9, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.