GE Healthcare Recalls SIGNA PET/MR 3.0T Scanners for SAR Display Error
GE Healthcare is recalling 17 SIGNA PET/MR 3.0T scanners because displayed SAR values may be lower than actual levels, potentially exceeding safety limits during head or neck scans.
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 (medical device) where the safety limit for SAR exposure may be exceeded, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare is recalling 17 units of the SIGNA PET/MR 3.0T system. The recall is due to a software issue 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 body when exposed to radiofrequency fields.
According to SAR modeling, the actual SAR in the head could exceed the IEC60601-2-33 safety limit of 3.2 W/kg for some scans. This discrepancy means the safety limits indicated on the device interface may not accurately reflect the exposure levels experienced by the patient.
The affected units are distributed worldwide, including in the United States (nationwide including DC, PR, and GU) and numerous international locations. The recall is classified as Class II by the FDA. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue and ensure patient safety.
The recalled product
- Product
- GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquir
- Manufacturer
- GE Healthcare
- Affected units
- 17
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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