MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging… recallZ-2135-2016 · Toshiba American Medical Systems Inc · initiated Apr 14, 2016
Class II Terminated All recalls posted in July 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Toshiba American Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
FDA root cause category: Device Design
What the company is doing
An Urgent Medical Device Notification letter was sent to customers to alert them to a potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. The letter informs the customers of the problem identify and the corrective action. Customers are informed that their Toshiba service representative will contact them for an appointment to install the modified software on their system when it becomes available. Customers are instructed to complete the attached customer response form and fax it to the toll-free number shown at the top of the form; sent via email to [email protected]. Customers with any questions are instructed to contact Paul Biggins at (800) 421-1968 or to contact their local Toshiba representative at (800) 521-1968.
Recall details
- Recall number
- Z-2135-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 14, 2016
- Posted by the FDA
- Jul 6, 2016
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 33 units
- Product code
- LNH
- FDA submissions
- K152371
- Distribution
- US Nationwide Distribution
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.
Code information (models, lots, serial 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
Other devices under the same FDA submission
1 device cleared under K152371 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vantage Titan 3T MRT-3010Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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