Z-0281-06

Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR...

Name: Z-0281-06 Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR...
Creator: Toshiba American Med Sys Inc
Published: 2005-10-12
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2005-10-12 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and... on 2005-10-12. The reason FDA records is "To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0281-06
Status: Terminated
Initiated: 2005-10-12
Posted: 2005-12-14
Terminated: 2007-07-12
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.
FDA root cause: Other
Action: Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance.
Quantity in commerce: 65
Distribution: Nationwide
Product codes and lots: Serial Numbers: A4622037, A4612031, A4622017, A4532013, A4582010, A5532048, A4592013, A4532012, A5532022, A4602028, A3592003, A4522007, A5512041, A4612015, A4572020, A4602029, A4622039, A4612030, A4542015, A4602014, A4602026, A4622036, A5522045, A5532047, A4612033, A5512040, A4612032, A4562003, A4572004, A4592012, A4562018, A4622035, A4522009, A4602025, A3582001, A5512043, A45320 11, A4602024, A5512018, A4572006, A4572023, A5512019, A5532049, A3592002, A4602027, A4552002, A4512006, A4552017, A5522046, A4572005, A4562019, A4572021, A4522008, A4612034, A4582009, A3612004, A4622016, A4532010, A3622001, A5512044, A4552016, A4572007, A4592011, A4572008, & A5512042

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)