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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Toshiba American Medical Systems Inc
Reason for Recall:
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2135-2016

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