The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0256-2016·Announced 2015-11-18

GE Healthcare Recalls SIGNA Excite 3.0T MR Systems for SAR Display Error

GE Healthcare is recalling 55 SIGNA Excite 3.0T MR systems because displayed SAR values may be lower than actual head SAR levels during scans.

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 (medical device) where the hazard (exceeding SAR limits) is identified through modeling, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare is recalling 55 units of the SIGNA Excite 3.0T MR System, a diagnostic imaging device. The recall affects units distributed worldwide, including the United States, Puerto Rico, Guam, and numerous international locations.

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 modeling indicates that the actual SAR in the head could exceed the IEC60601-2-33 limit of 3.2 W/kg for some scans. This discrepancy could result in patients receiving higher radiofrequency energy exposure than intended during specific imaging procedures.

Healthcare facilities and users of these systems should contact GE Healthcare for instructions on how to resolve the issue. The source text does not specify a particular action for consumers or patients, but the recall is directed at the medical device operators.

The recalled product

Product
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
Manufacturer
GE Healthcare
Category
Medical Device — Magnetic Resonance Imaging (MRI)
Hazard
Affected units
55

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 →

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