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Recall Observatory FDA recall evidence

Device 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.

Z-2278-2012

May 13, 2008

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 62853
Status
Terminated
Classification
Class II
Quantity
54
Official record key
device-enforcement:Z-2278-2012

Official wording

Reason: The status display in the sequence queue window may not change from "Current" to "Done".

Code information: 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

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The status display in the sequence queue window may not change from "Current" to "Done".