FDA Device recall Z-0875-2026
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- FDA Device
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography by Ge Medical Systems, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0875-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-24 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | n/a |
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).
Identifiers
| code_info | GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0875-2026%22
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