GE Healthcare Recalls Signa HDx 3.0T MRI Scanners for SAR Display Error
GE Healthcare is recalling 350 Signa HDx 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR levels, 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 safety limit for SAR exposure may be exceeded, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
GE Healthcare is recalling 350 units of the Signa HDx 3.0T magnetic resonance (MR) scanner. The recall is due to a defect where the Specific Absorption Rate (SAR) values displayed during head or neck scans may be lower than the actual SAR in the head. SAR is a measure of the rate at which energy is absorbed by the human body when exposed to a radio frequency electromagnetic field.
The issue arises because the predicted HEAD SAR value from modeling suggests that the actual SAR in the head could exceed the IEC60601-2-33 limit of 3.2 W/kg for some scans. This discrepancy means the safety limits indicated on the scanner's display may not accurately reflect the exposure levels experienced by patients during specific imaging procedures.
The affected units were distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, Africa, and the Americas. The source text does not report any illnesses or injuries associated with this defect. Healthcare facilities using these scanners should contact GE Healthcare for instructions on how to address the issue.
The recalled product
- Product
- GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
- Manufacturer
- GE Healthcare
- Affected units
- 350
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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