# FDA recall Z-0875-2026

> **GE Medical Systems, LLC** · Class II · device recall initiated 2025-10-24.

## Product

Senographe Pristina, Pristina Serena, and Pristina Serena 3D.  for screening and diagnostic mammography

## Reason for recall

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).

## Distribution

U.S. and OUS.

## Key facts

- **Recall number:** Z-0875-2026
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-24
- **Report date:** 2025-12-17

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2026

## Citation

> AI Analytics. FDA recall Z-0875-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0875-2026. Source: US FDA. Licensed CC0.

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