Reported Jul 21, 2021 · Ongoing
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - 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 Titan 3T, Premium Open-Bore MRI System
- REFMRT-3010 -
- 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
A5B1182002A5B11Y2005A5D14X2032A5A1082001A5C12Y2017A5D13Y2025A5C1412028S7A1642006A5D13Y2026A5F1562034A5B1192004A5C1222010A5C1212009A5C12X2016A5G1692038A5G1642036A5C1232011A5C1252012A5D13Z2027A5D1492030A5C1262013A5E1522033A5G1692039A5D14X2031A5B1192003A5B11Y2006A5D1312019A5G1652037A5D1362021A5C1292015A5D13X2024A5C1422029A5D1322020A5B11Z2007A5C1212008A5C12Z2018A5D1372022
- 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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