MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan...
FDA Device Recall #Z-2135-2016 — Class II — April 14, 2016
Recall Summary
| Recall Number | Z-2135-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 14, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Toshiba American Medical Systems Inc |
| Location | Tustin, CA |
| Product Type | Devices |
| Quantity | 33 units |
Product Description
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interface designed for ease of use.
Reason for Recall
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
A5A1082001 A5B1182002 A5B1192003 A5B1192004 A5B11Y2005 A5B11Y2006 A5B11Z2007 A5C1212008 A5C1212009 A5C1222010 A5C1232011 A5C1252012 A5C1262013 A5C1282014 A5C1292015 A5C12X2016 A5C12Y2017 A5C12Z2018 A5D1312019 A5D1322020 A5D1362021 A5D1392023 A5D13X2024 A5D13Y2025 A5D13Y2026 A5D13Z2027 A5C1412028 A5C1422029 A5D1492030 A5D14X2031 A5D14X2032 A5E1522033 A5F1592035 A5D1372022 A5P1562034
Other Recalls from Toshiba American Medical Systems Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2315-2018 | Class II | Diagnostic Ultrasound System, Aplio I-series. ... | Jan 4, 2018 |
| Z-0843-2018 | Class II | INFX-8000C Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0842-2018 | Class II | INFX-8000F Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0845-2018 | Class II | INFX-8000H Fluoroscopic X-Ray Systems | Dec 29, 2017 |
| Z-0844-2018 | Class II | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX ... | Dec 29, 2017 |
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.