GE Healthcare Recalls Signa HDxt 3.0T MRI Scanners for SAR Limit Concerns
GE Healthcare is recalling 215 Signa HDxt 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR, 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 scanner) where the hazard is a potential exceedance of safety limits (SAR) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 215 units of the Signa HDxt 3.0T whole body magnetic resonance scanner. The recall affects the 1.5T and 3.0T Signa HDx families used for diagnostic imaging. The devices were distributed worldwide, including nationwide in the United States and in numerous international markets.
The recall is issued because, during head or neck scans, the currently displayed Specific Absorption Rate (SAR) values could be lower than the actual SAR in the head. Modeling predicts that the actual head SAR could exceed the IEC60601-2-33 limit of 3.2 W/kg for some scans. This discrepancy means the safety limits displayed to operators may not accurately reflect the actual energy absorbed by the patient's head.
The recall is classified as Class II by the FDA. No specific instructions for end-users are provided in the source text, but the recall is directed at the medical device itself to address the potential safety limit exceedance.
The recalled product
- Product
- GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Scanner
- Affected units
- 215
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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