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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 62928
Product Type Devices
Status Completed
Recalling Firm Toshiba American Medical Systems Inc
City Tustin
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern US (nationwide) distribution including the states of Ohio and Texas.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging. MRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143. Class II 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. 3 units Z-2315-2012