Z-1045-04

Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE

Name: Z-1045-04 Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE
Creator: Toshiba American Med Sys Inc
Published: 2004-06-07
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-06-07 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE on 2004-06-07. The reason FDA records is "Wrong positioning may cause patient burns". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1045-04
Status: Terminated
Initiated: 2004-06-07
Posted: 2004-07-20
Terminated: 2005-01-04
Recalling firm: Canon Medical Systems USA, Inc.
Product: Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Wrong positioning may cause patient burns.
FDA root cause: Other
Action: An advisory letter will issue to all users May 26, 2004, with updated positioning information, and an employee will visit to make sure the letter was received and understood.
Quantity in commerce: 58
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)