GE Healthcare Recalls Discovery MR750w MRI Scanners Due to Burn Risk
GE Healthcare is recalling 471 Discovery MR750w MRI scanners because a small area of the patient bore can become warm enough to cause a serious burn if proper padding is not used.
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 3/5 (High).
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 serious burn injury, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 471 units of the Discovery MR750w MRI scanner. The recall affects 184 units in the United States and 287 units outside the US. The devices are distributed across numerous US states and territories, as well as many international locations.
The recall is due to a potential safety issue with the patient bore heating. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn if the patient touches the bore and proper padding is not used. GE Healthcare has not reported any injuries resulting from this issue.
Healthcare facilities should contact GE Healthcare for instructions on how to address the issue, including the use of proper padding to prevent patient contact with the affected area.
The recalled product
- Product
- GE Healthcare, Discovery MR750w
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Scanner
- Hazard
Distribution
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