Reported Jul 21, 2021 · Ongoing
Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System
- REFMRT-1504 -
- Product Usageuse as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA
- Lot codes and dates
- Affected serial numbers
232 of 232 codes
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
- Affected serial numbers
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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