Enforcement Report - Week of September 12, 2012
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Product Detail
| Product Description | Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging. |
|---|---|
| Recall Number | Z-2315-2012 |
| Classification | Class II |
| Code Info | MRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143. |
| Product Distributed Qty | 3 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. |
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 | Letter |
| Distribution Pattern | US (nationwide) distribution including the states of Ohio and Texas. |
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