Z-1101-2013Class II

MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System

Name: Z-1101-2013 MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System
Creator: Toshiba American Medical Systems Inc
Published: 2012-10-15
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2012-10-15 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System on 2012-10-15. FDA classified it as Class II and gives the reason as "It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing...". 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-1101-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-15
Posted: 2013-04-11
Terminated: 2013-11-06
Recalling firm: Canon Medical Systems USA, Inc.
Product: MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Toshiba sent an Urgent Medical Device Correction letter dated October 1, 2012 via USPS return receipt mail to all affected customers . The letter identified the affected product, problem and actions to be taken. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions contact your local Toshiba representative at 800-521-1968.
Quantity in commerce: 27 units
Distribution: USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.
Product codes and lots: Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1101-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1101-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-11

Product code LNH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)