Z-2135-2016Class II

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

Name: Z-2135-2016 MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System
Creator: Toshiba American Medical Systems Inc
Published: 2016-04-14
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-04-14 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of 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... on 2016-04-14. FDA classified it as Class II and gives the reason as "A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2135-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Posted: 2016-07-06
Terminated: 2017-03-30
Recalling firm: Canon Medical Systems USA, Inc.
Product: 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 code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 33 units
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2135-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2135-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code LNH

K152371Class IIVantage Titan 3TToshibamedical Systems Corporation / cleared 2015-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)