CLASS II Device recall · Reported 13 Jul 2016 · FDA Enforcement Report

Mexl-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System recalled

Toshiba American Medical Systems is recalling Mexl-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System, distributed nationwide in the US. The recall was initiated on 14 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA5A1082001 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

Quantity recalled33 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2135-2016
FDA event ID: 74454
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Apr 2016
FDA classified: 6 Jul 2016
Reported: 13 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

14 Apr 2016	Recall initiated by company
6 Jul 2016	Classified by FDA	+83 days
13 Jul 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.

Which lots are affected?

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

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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