NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1...
FDA Device Recall #Z-0773-2019 — Class II — January 9, 2019
Recall Summary
| Recall Number | Z-0773-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 9, 2019 |
| Status | Terminated |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | NEUSOFT MEDICAL SYSTEMS IMP & EX |
| Location | Shenyang |
| Product Type | Devices |
| Quantity | 3 |
Product Description
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Reason for Recall
For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
Distribution Pattern
US Distribution in states of: KS, OK and MA.
Lot / Code Information
Series number includes: N1281180242E, N1281170231E, N1281180248E
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.