Senographe Pristina — Class II medical device recall Z-0875-2026
Ongoing recall by GE Medical Systems, LLC, reported 2025-12-17. Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconf
| Recall number | Z-0875-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-10-24 |
| Classified | 2025-12-09 |
| Reported by FDA | 2025-12-17 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026, 00840682118460, 00840682142052, 00840682145879 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0875-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.