Toshiba MRI Systems Recalled for Sequence Queue Status Display Error
Toshiba American Medical Systems is recalling 54 EXCELART MRI systems because the status display in the sequence queue window may fail to update from 'Current' to 'Done'.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect is a software display error that does not explicitly report injuries, hospitalizations, or structural failures, fitting the criteria for a moderate severity recall involving potential operational issues without confirmed harm.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 54 EXCELART Vantage, Atlas, and Titan MRI Systems, specifically models MRT-1503 and MRT-1504. The recall involves specific software versions: MRT-1503 systems with software V9.01 *R240 through V9.20*R242, and MRT-1504 systems with software V9.21 *R24. These devices were distributed nationwide.
The recall is due to a software defect where the status display in the sequence queue window may not change from "Current" to "Done". This issue affects the visual confirmation of scan completion within the user interface.
Healthcare facilities using these MRI systems should contact Toshiba American Medical Systems Inc for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- 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.
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — MRI Systems
- Affected units
- 54
Distribution
Distributed nationwide across the United States.
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