Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 24, 2025 |
| Reported | December 17, 2025 |
| Recalling firm | GE Medical Systems, LLC |
| Country / region | United States WI |
Hazard
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).
Affected products
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
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