FDAFDA · Food and drugs·Recall number Z-2278-2012
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
Published September 5, 2012 · Recall initiated: May 13, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The status display in the sequence queue window may not change from "Current" to "Done".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- Nationwide Distribution
- Lot
- Models MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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