Agency classClass IIOur severity:High FDA (Devices)·Z-2474-2024·Announced 2024-08-14

SIGNA MR380 MRI system software may exceed implant heating limits

GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.

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: This is an FDA Class II medical device recall. While no injuries or illnesses have been reported, the defect presents a risk of harm to patients with MR-conditional implants through excessive heating. Per the severity rubric, this constitutes 'High' severity as a risk-of-harm product where no injury has yet been reported.

Plain-English summary

The SIGNA MR380 magnetic resonance imaging (MRI) system, manufactured by GE Medical Systems, LLC, is subject to this recall. Affected systems have software versions SV25.5 or SV25.6. Approximately 206 units have been distributed worldwide.

The system can exceed the user-prescribed radiofrequency (B1+RMS) limit during Low SAR Mode imaging when two conditions are present simultaneously: (1) a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected, and (2) the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration. When these conditions occur, the system's predicted radiofrequency heating value exceeds safety limits.

If radiofrequency heating exceeds the prescribed limit, MR-conditional implants may overheat during patient scanning, potentially causing harm to patients. No injuries or illnesses have been reported in connection with this issue to date.

The recalled product

Product: SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — MRI System
Hazard: implant-overheating
rf-heating
software-defect
Affected units: 206

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

System ID: 082427220113
082427220120
082427220099
082427310159
082427220101
82427140311
082427140312
082427100465
082427110158
082427140254
082427070286
082427110136
082427040296
082427040293
082427180072
082427150126
082427150125
082427140266
082427140239
082427090462

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 26 recalled by GE Medical Systems, LLC 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 26 products in this recall →

Same manufacturer · GE Medical Systems, LLC

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