The Recall Desk
HighFDA (Devices)·Z-2482-2024·Announced 2024-08-14

MRI System Software Error Can Cause Implant Overheating in Low SAR Mode

GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.

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 involving a software error that creates a risk of overheating in MR-conditional implants. No hospitalizations or injuries have been reported in the source, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE HealthCare has issued a recall for the Discovery MR950 Nuclear Magnetic Resonance (MRI) imaging system running software version 7T23.0, used for research purposes. The system is identified as System ID: EX0001.

The system's software contains a calculation error in the predicted B1+RMS value, which measures radiofrequency heating safety limits. Under specific conditions—when the system operates in Low SAR Mode while using either 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences with the Optimized T2 FLAIR option turned off or not included—the predicted heating value can exceed the user-prescribed limit. This error can result in overheating of MR-conditional implants during patient scanning.

Affected users should contact GE HealthCare for software updates or corrective measures. Facilities using this system should restrict the identified imaging sequences, ensure the Optimized T2 FLAIR option is enabled, or implement other mitigation measures provided by GE HealthCare until a permanent fix is available.

The recalled product

Product
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Magnetic Resonance Imaging System
Hazard
  • software-malfunction
  • overheating
  • implant-heating

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: EX0001

Distribution

Distribution scope not specified by the agency.

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