Z-0201-2014Class II

Titan 3T MRI System, MRT-3010A/5

Name: Z-0201-2014 Titan 3T MRI System, MRT-3010A/5
Creator: Toshiba American Medical Systems Inc
Published: 2013-10-28
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2013-10-28 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system on 2013-10-28. FDA classified it as Class II and gives the reason as "Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0201-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-11-13
Terminated: 2014-12-24
Recalling firm: Canon Medical Systems USA, Inc.
Product: Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Toshiba America Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION". letter dated October 28, 2013 via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. The letter listed Device, Serial Number, reason for recall, problem, corrective actions, request to customers, and contact information.
Quantity in commerce: 18 units
Distribution: USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Product codes and lots: Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0201-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0201-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-12

Product code LNH

K102489Class IIVantage Titan 3TToshiba Medical Systems Corporation, Japan / cleared 2011-08-02

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)