Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
FDA Recall Z-2315-2012 · Posted 2012-09-06
Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-02-21
Date Terminated2012-09-07
Product Quantity3 units
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
US (nationwide) distribution including the states of Ohio and Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.