Senographe Pristina
FDA device recall Z-0862-2024 · posted 2024-02-08 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems, SCS
- 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.
- Action taken
- GE HealthCare will, without charge, remedy the defect or bring the product into compliance. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- MUE
- Quantity affected
- 180 units (60 US; 120 OUS)
- Distribution
- Us Nationwide-Worldwide Distribution
- Date initiated
- 2023-12-26
- Date posted
- 2024-02-08
- Location
- Buc, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SenoBright HD (K211215) | GE Healthcare | 2021-06-22 |
| Pristina Serena Bright (K193334) | GE Healthcare | 2020-05-15 |
| Pristina Serena 3D (K182951) | GE Healthcare | 2019-01-18 |
| Pristina Serena (K173576) | GE Healthcare | 2018-05-14 |
| Senographe Pristina (K162268) | GE Healthcare | 2016-11-03 |