Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure
Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for potential fire and smoke hazard from a component failing to meet flame retardancy requirements. Per the rubric, risk-of-harm products without reported injuries are scored High (3), as the hazard is real but no illnesses or deaths have been reported.
Plain-English summary
Canon Medical System, USA, INC. is recalling Canon Vantage Tiitan 1.5T MRI Systems (Model REF: MRT-1510) due to a component that does not meet appropriate flame retardancy standards. This component could result in smoke or fire.
The affected MRI systems are identified by specific serial numbers listed in the recall notice. The systems were distributed nationwide across all U.S. states and territories.
Facilities operating affected systems should contact Canon Medical System, USA, INC. for guidance on remediation or replacement of the non-compliant component.
The recalled product
- Product
- Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use 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 sy
- Manufacturer
- Canon Medical System, USA, INC.
- Hazard
- fire
- smoke
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Affected Serial Numbers: S3C18Y2032
- S3C1892029
- S3C1912035
- S3C2042045
- S3A16Z2007
- S3B1782012
- S3A1692003
- S3C1912036
- S3C2012043
- S3C1882028
- S3C19Z2042
- S3B17Y2016
- S3C1842019
- S3C1912034
- S3C18Z2033
- S3C2012044
- S3C2082046
- S3B1762010
- S3B1762009
- S3C1872025
Distribution
Distributed nationwide across the United States.
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