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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 Recall
Toshiba UltraShort Magnetic Resonance Imaging System
see related information
Date Posted September 06, 2012
Recall Status1 Terminated on September 07, 2012
Recall Number Z-2315-2012
Recall Event ID 62928
Premarket Notification
510(K) Number
K060003 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Toshiba 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, California 92780-7047
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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 toraffairs@tams.com. 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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