GE Healthcare Recalls MRI Scanners Due to Potential SAR Limit Exceedance
GE Healthcare is recalling 756 MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits during head or neck scans.
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-harm product (medical device) where the hazard is a potential exceedance of safety limits (SAR), but no injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare is recalling 756 units of the Discovery MR750w 3.0T and related MRI scanner models. The recall affects whole-body magnetic resonance scanners used for diagnostic imaging, including the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T systems.
The recall was initiated because, during head or neck scans, the currently displayed Specific Absorption Rate (SAR) values could be lower than the actual SAR in the head. SAR modeling predicts that the actual SAR in the head could exceed the IEC60601-2-33 limit of 3.2 W/kg for some scans.
The affected units were distributed worldwide, including nationwide in the United States (including DC, PR, and GU) and in numerous international countries. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 756
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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