Z-0061-05

Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System

Name: Z-0061-05 Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System
Creator: Toshiba American Med Sys Inc
Published: 2004-09-16
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2004-09-16 / Terminated / root cause: software

FDA source

Toshiba American Med Sys Inc began a recall of Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System on 2004-09-16. The reason FDA records is "Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly". 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-0061-05
Status: Terminated
Initiated: 2004-09-16
Posted: 2004-11-02
Terminated: 2005-07-13
Recalling firm: Canon Medical Systems USA, Inc.
Product: Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.
Root cause tag: software
FDA root cause: Other
Action: Firm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update.
Quantity in commerce: 22
Distribution: PA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN.
Product codes and lots: Serial numbers: A4512006, A452017, A4532011, A3612004, A4532014, A4572020, A4572021, A3622005, A4562003, A3592003, A4562018, A4522008, A4532010, A4542015, A4532013, A3622001, A3582001, A4522009, A4532012, A3592002, A4522007, A4552016.

Product code LNH

K032490Class IIToshiba Excelart Vantage Xgv/agv MRI Diagnostic System, Models Mrt-1503/P3 and Mrt-1503/P2Toshiba America Medical Systems, In.C / cleared 2003-08-21

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)