Reported Jul 21, 2021 · Ongoing
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging…
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?
- Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System
- REFMRT-1510 -
- 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
S3C18Y2032S3C1892029S3C1912035S3C2042045S3A16Z2007S3B1782012S3A1692003S3C1912036S3C2012043S3C1882028S3C19Z2042S3B17Y2016S3C1842019S3C1912034S3C18Z2033S3C2012044S3C2082046S3B1762010S3B1762009S3C1872025S3C1932039S3C1812017S3C19Z2041S3C1832018S3B17X2015S3A16Z2006S3C1852021S3C18X2030S3C1932040S3C1922038S3A16Y2004S3B1782013S3C1842020S3C1882026S3C1912037S3B1772011S3A16Z2005S3C1882027S3B1782014
- 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.
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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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