---
title: "Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening a... — FDA record Z-0875-2026 | Is It on Recall"
description: "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)."
url: https://isitonrecall.com/recall/fda-device-z-0875-2026-senographe-pristina-pristina-serena-and-pristina-serena-3d-for-screening-and-diagnostic-mammography/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0875-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0875-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [GE Medical Systems, LLC records](https://isitonrecall.com/brand/ge-medical-systems-llc/)