GE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk
GE Healthcare is recalling 60 Discovery MR450 MRI scanners because a component failure can cause the patient bore to heat up, potentially leading to serious burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the hazard 'may cause a serious burn,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.
Plain-English summary
GE Healthcare, LLC is recalling 60 units of the Discovery MR450 whole body magnetic resonance scanners. These devices are used for diagnostic imaging of various body parts. The recall is due to a potential safety issue where the patient bore may heat up abnormally.
The hazard occurs if a radio frequency (RF) component fails, typically after extended system use. In this scenario, a small area on the bore surface may become warmer than normal. If a patient is in contact with this area and proper padding is not used, it may cause a serious burn.
The affected units were distributed worldwide, including in the United States and several international countries. Healthcare facilities should contact GE Healthcare for instructions on how to address this issue.
The recalled product
- Product
- Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 60
Distribution
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