NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part num...

FDA Device Recall #Z-2083-2012 — Class II — June 8, 2012

Recall Summary

Recall Number Z-2083-2012
Classification Class II — Moderate risk
Date Initiated June 8, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips And Neusoft Medical Systems Co., Ltd.
Location Shenyang, Liaoning
Product Type Devices
Quantity 15 units distributed in the US

Product Description

NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

Reason for Recall

One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

Distribution Pattern

Nationwide Distribution -- North Carolina, Ohio, and Texas.

Lot / Code Information

Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.

Other Recalls from Philips And Neusoft Medical Systems C...

Recall # Classification Product Date
Z-1573-2016 Class II NeuViz 16 Multi-Slice CT Scanner System PN: 989... Mar 24, 2016
Z-1165-2013 Class II NeuViz 16 Multi-Slice CT Scanner System, Part n... Mar 4, 2013
Z-1166-2013 Class II NeuViz Dual series CT Scanner System, Part n... Mar 4, 2013
Z-0466-2013 Class II NeuViz 16 Multi-Sliced CT Scanner System, part ... Oct 18, 2012

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.