Agency classClass IIOur severity:High FDA (Devices)·Z-0257-2016·Announced 2015-11-18

GE Healthcare Recalls Signa HD 3.0T MRI Systems Due to SAR Display Error

GE Healthcare is recalling 97 Signa HD 3.0T MRI systems 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 system) where the safety limit for Specific Absorption Rate (SAR) may be exceeded, but no injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare is recalling 97 units of the Signa HD 3.0T MRI system, an open, whole-body diagnostic imaging device. The recall covers units distributed worldwide, including the United States and numerous international locations.

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. SAR modeling predicts 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 displayed to operators may not accurately reflect the energy absorbed by the patient's head.

The affected units are identified by specific serial numbers listed in the recall documentation. Healthcare facilities using these devices should contact GE Healthcare for instructions on how to resolve the issue and ensure patient safety during imaging procedures.

The recalled product

Product: GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room…
Manufacturer: GE Healthcare
Category: Medical Device — Magnetic Resonance Imaging (MRI)
Hazard: sar-exposure
display-error
Affected units: 97

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