Canon MRI Systems Recall Due to SAR Display Error
Canon Medical System is recalling 252 MRI systems because the displayed SAR value may be lower than the actual value, potentially exceeding safety limits.
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: The recall involves a risk-of-harm product (MRI system) where the actual SAR values may exceed safety limits, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Canon Medical System, USA, INC. is recalling 252 Nuclear Magnetic Resonance Imaging (MRI) systems. The affected units are indicated for use as a diagnostic imaging modality that produces cross-sectional images of the head or body.
The recall is due to a software issue where, when using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the Specific Absorption Rate (SAR) value displayed on the console may be lower than the actual SAR value. Consequently, the actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
The affected units were distributed domestically in 41 states and internationally in 40 countries. No specific instructions for consumers are provided in the source text, but the recall indicates a need to address the discrepancy between displayed and actual SAR values to ensure compliance with safety limits.
The recalled product
- Product
- Nuclear Magnetic Resonance Imaging Systems that are indicated for 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.
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — MRI Systems
- Hazard
- Affected units
- 252
Distribution
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