The Recall Desk
HighFDA (Devices)·Z-2484-2024·Announced 2024-08-14

SIGNA MAGNUS MRI Software Can Overheat Implanted Devices

GE Medical Systems recalled SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. Under specific imaging conditions in Low SAR Mode, the system may exceed safe radiofrequency power limits and cause implanted medical devices to overheat.

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 recall of a medical imaging system where software can cause radiofrequency power to exceed safe limits, potentially overheating implanted medical devices. No injuries or illnesses have been reported, making this a risk-of-harm scenario with theoretical rather than demonstrated harm.

Plain-English summary

GE Medical Systems has recalled the SIGNA MAGNUS Nuclear Magnetic Resonance (NMR) imaging system with affected software versions MR29.1 and RX29.1. The issue involves a software calculation error: when the system operates in Low SAR Mode using either 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences with the Optimized T2 FLAIR option disabled or not included, the predicted radiofrequency power output (B1+RMS value) can exceed the user-prescribed safety limit.

One SIGNA MAGNUS system is affected (System ID: 608BUCKYS3T), with worldwide distribution. The primary concern is patients with MR conditional implants—implanted medical devices such as pacemakers or neurostimulators that are approved for use in MRI environments only under specific, controlled conditions. If the radiofrequency power exceeds the prescribed limit, the implant can overheat, potentially causing tissue damage or device malfunction.

This recall notification from GE Medical Systems alerts facilities and healthcare providers to the issue. Facilities with the affected system should contact GE Medical Systems for information on software corrections or other remedies. In the interim, users should be aware of the specific imaging sequence and configuration that can trigger the issue.

The recalled product

Product
SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
  • implant-overheating
  • software-error
  • burn-injury

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 (1)

  • System ID: 608BUCKYS3T

Distribution

Distribution scope not specified by the agency.

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