Senographe Pristina — Class II medical device recall Z-0862-2024
Ongoing recall by GE Medical Systems, SCS, reported 2024-02-14, distributed nationwide. X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not em
| Recall number | Z-0862-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Medical Systems, SCS, Buc, France |
| Recall initiated | 2023-12-26 |
| Classified | 2024-02-08 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00195278022745, 00195278276971, 00195278628916, 00195278661999, 00195278665379, 00840682118460, 00840682142052, 00840682145879 |
Product
Senographe Pristina
Reason for recall
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
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-0862-2024. 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.