Reported Jul 21, 2021 · Ongoing
Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces…
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 Galan 3T
- REFMRT-3020 -
- 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
D5A2082005S7B1992017S5C1912050S5A1662001D5A2092007S5B17X2034S5B18X2046S5A17X2033S5A1742021D5A2062003S5C18Y2048S5A1732019S5A1732018S5A17Y2035S7B1892004S5B1842043S7B1962013S5C1972054
- 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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