Z-2315-2012Class II

Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR...

Name: Z-2315-2012 Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR...
Creator: Toshiba American Medical Systems Inc
Published: 2012-02-21
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2012-02-21 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging on 2012-02-21. FDA classified it as Class II and gives the reason as "The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2315-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-21
Posted: 2012-09-06
Terminated: 2012-09-07
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
FDA root cause: Component change control
Action: Toshiba America Medical Systems, Inc, sent a Urgent Medical Device Correction letter dated February 21, 2012, via USPS return receipt mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you subsequently find that images are abnormally noisy compared to images acquired under the same conditions in the system before this modification was performed, contact your Toshiba Service Representative. Please share this information with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. Please complete and return the attached form and fax it to the toll free number at the top of the form. This form can also be sent via email [email protected]. Contact information was also provided (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 3 units
Distribution: US (nationwide) distribution including the states of Ohio and Texas.
Product codes and lots: MRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2315-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2315-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code LNH

K060003Class IIExcelart Vantage ZgvToshibamedical Systems Corporation / cleared 2006-01-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)