GE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error
GE Healthcare is recalling 19 Signa 3.0T MRI systems because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.
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 (exposure to radiation exceeding safety limits) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling 19 units of the Signa 3.0T MRI system, specifically the Transmit/Receive Body Imaging Coil, due to a software issue affecting Specific Absorption Rate (SAR) calculations. The recall involves systems distributed worldwide, including the United States and numerous international markets.
The recall is necessary because, during head or neck scans, the SAR values displayed on the system may be lower than the actual SAR in the head. Modeling predicts that the actual head SAR could exceed the IEC60601-2-33 safety limit of 3.2 W/kg for some scans. This discrepancy means the system may not accurately reflect the energy absorbed by the patient's head during imaging.
Healthcare facilities that have purchased or leased these specific units should contact GE Healthcare for instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The…
- Manufacturer
- GE Healthcare
- Affected units
- 19
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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