Recall Z-2278-2012— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2008-05-13, terminated 2012-09-04. It names 3 FDA 510(k) clearances: K080038, K063361, K032490. Product: 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.. Reason: The status display in the sequence queue window may not change from "Current" to "Done"..
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-05-13
- Terminated
- 2012-09-04
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K080038 — VANTAGE TITAN, MODEL MRT-1504/S3
- K063361 — EXCELART VANTAGE ATLAS, MODEL MRT-1503
- K032490 — TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The status display in the sequence queue window may not change from "Current" to "Done".
Data sourced from openFDA. This site is unofficial and independent of the FDA.