Reported Jul 13, 2016 · Terminated
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power…
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · PO Box 2068 · Tustin, CA · 92780-7047
Is this the product you have?
- MEXL-3010/A5- Vantage Titan 3T Magnetic
- Resonance Imaging System Product UsageVantage 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
- Lot codes and dates
A5A1082001A5B1182002A5B1192003A5B1192004A5B11Y2005A5B11Y2006A5B11Z2007A5C1212008A5C1212009A5C1222010A5C1232011A5C1252012A5C1262013A5C1282014A5C1292015A5C12X2016A5C12Y2017A5C12Z2018A5D1312019A5D1322020A5D1362021A5D1392023A5D13X2024A5D13Y2025A5D13Y2026A5D13Z2027A5C1412028A5C1422029A5D1492030A5D14X2031A5D14X2032A5E1522033A5F1592035A5D1372022A5P1562034
- Amount recalled
- 33 units
Where it was sold
- Nationwide
Why it was recalled
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
This product could cause temporary or reversible health problems — stop using it.
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