Agency classClass IIOur severity:High FDA (Devices)·Z-0258-2016·Announced 2015-11-18

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.

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 (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
Category: Medical Device — Diagnostic Imaging
Hazard: sar-exposure
display-error
Affected units: 350

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 7 products in this recall →

Same manufacturer · GE Healthcare

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Same hazard · sar exposure