Z-2278-2012Class II

EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid...

Name: Z-2278-2012 EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid...
Creator: Toshiba American Medical Systems Inc
Published: 2008-05-13
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2008-05-13 / Terminated / root cause: manufacturing process

FDA source

Toshiba American Medical Systems Inc began a recall of EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR... on 2008-05-13. FDA classified it as Class II and gives the reason as "The status display in the sequence queue window may not change from "Current" to "Done"". 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-2278-2012
Classification: Class II
Status: Terminated
Initiated: 2008-05-13
Posted: 2012-08-28
Terminated: 2012-09-04
Recalling firm: Canon Medical Systems USA, Inc.
Product: EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The status display in the sequence queue window may not change from "Current" to "Done".
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A recall notification letter titled: "URGENT: MEDICAL DEVICE CORRECTION," was sent to customers. The letter stated the problem, corrective action, and (instructions) request to customers. Customers were instructed to perform the temporary recovery procedures if the problem occurs. Additionally, the acknowledgement sheet should be completed and faxed back. The information should be shared with all users, including the bio-medical or clinical engineering departments. Questions pertaining to the information for this recall were to be directed to (800) 421-1968.
Quantity in commerce: 54
Distribution: Nationwide Distribution
Product codes and lots: Models MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2278-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2278-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

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)