Z-0270-05

Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3...

Name: Z-0270-05 Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3...
Creator: Toshiba American Med Sys Inc
Published: 2004-10-06
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-10-06 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN Excelart VANTAGE on 2004-10-06. The reason FDA records is "Software defect causes images to be rotated 180 degrees". 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-0270-05
Status: Terminated
Initiated: 2004-10-06
Posted: 2004-12-02
Terminated: 2005-09-02
Recalling firm: Canon Medical Systems USA, Inc.
Product: Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN Excelart VANTAGE
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Software defect causes images to be rotated 180 degrees.
Root cause tag: software
FDA root cause: Other
Action: Firm sent a letter to consignees October 6, 2004 describing the observed conditions causing the flaw to manifest itself. A workaround solution is also described in the letter. A software correction is under development and will be installed by a TAMS representative in the future.
Quantity in commerce: 67
Distribution: Nationwide
Product codes and lots: All serial numbers.

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)