The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · implant overheating

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