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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba UltraShort Magnetic Resonance Imaging System

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 Class 2 Device Recall Toshiba UltraShort Magnetic Resonance Imaging Systemsee related information
Date Initiated by FirmFebruary 21, 2012
Date PostedSeptember 06, 2012
Recall Status1 Terminated 3 on September 07, 2012
Recall NumberZ-2315-2012
Recall Event ID 62928
510(K)NumberK060003 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductToshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Code Information MRT-1503/P5-Vantage MRI System.  Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143.
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer 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 Determined
Cause 2		Component change control
ActionToshiba 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 toraffairs@tams.com. Contact information was also provided (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in Commerce3 units
DistributionUS (nationwide) distribution including the states of Ohio and Texas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
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