Senographe Pristina
FDA Device Recall #Z-0862-2024 - Class II, December 26, 2023
Recall Summary
| Recall Number | Z-0862-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 26, 2023 |
| Status | Ongoing |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | GE Medical Systems, SCS |
| Location | Buc |
| Product Type | Devices |
| Quantity | 180 units (60 US; 120 OUS) |
Product Description
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.
Distribution Pattern
Us Nationwide-Worldwide Distribution
Lot / Code Information
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Other Recalls from GE Medical Systems, SCS
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0068-2026 | Class II | AW Server 2.0, AW Server 3.0, AW Server 3.1, AW... | Sep 5, 2025 |
| Z-1781-2024 | Class II | GE Healthcare Allia IGS 7 OR, Interventional f... | Mar 18, 2024 |
| Z-1779-2024 | Class II | GE Healthcare Interact Discovery RT, Intervent... | Mar 18, 2024 |
| Z-1783-2024 | Class II | GE Healthcare Allia IGS 5 Pulse, Interventiona... | Mar 18, 2024 |
| Z-1777-2024 | Class II | GE Healthcare Innova IGS 5, computed tomography... | Mar 18, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.