Z-0546-04

Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models

Name: Z-0546-04 Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models
Creator: Toshiba American Med Sys Inc
Published: 2004-01-27
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-01-27 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models on 2004-01-27. The reason FDA records is "Software anomally causes image slices to be in incorrect order". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0546-04
Status: Terminated
Initiated: 2004-01-27
Posted: 2004-07-20
Terminated: 2005-07-13
Recalling firm: Canon Medical Systems USA, Inc.
Product: Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Software anomally causes image slices to be in incorrect order.
Root cause tag: software
FDA root cause: Other
Action: Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.
Quantity in commerce: 24
Distribution: NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
Product codes and lots: Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with softare V4.04*R251 to V4.10*R271.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)