Reported Mar 13, 2024 · Ongoing
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
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?
- MRI systemVantage Orian, Vantage Fortian
- ModelMRT-1550
- Lot codes and dates
- UDI-DI
0498767010336004987670104831
- Serial Numbers
118 of 118 codes
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
- UDI-DI
- Amount recalled
- 118
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
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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