The Recall Desk
HighFDA (Devices)·Z-2465-2024·Announced 2024-08-14

GE Discovery MR750w MRI System Software May Overheat Implants

GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, 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 a risk-of-harm product where potential serious injury (implant overheating) has not yet been reported. The hazard is documented but requires specific scanning conditions and configuration settings to occur. FDA Class II classification supports elevated severity, but absence of reported illnesses or implant-related incidents limits the score to 3.

Plain-English summary

GE HealthCare issued a recall of the Discovery MR750w 3.0T MRI system (724 units with worldwide distribution) with specific software versions (DV24.0, DV25.0, DV25.1, DV26.0–DV26.5, DV29.1, MR30.0, MR30.1). The recall was issued due to a software issue affecting the B1+RMS magnetic field strength calculation.

When 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences are used with the Optimized T2 FLAIR option turned off (or not included in the system configuration) while the system is in Low SAR Mode, the predicted B1+RMS value can exceed the user-prescribed limit. This overage can cause overheating of MR-conditional implants—specialized implants designed to remain safe only at certain magnetic field strengths.

The issue occurs only when specific scanning parameters and imaging sequences are combined with a particular system configuration. No illnesses or implant-related incidents have been reported as of this recall notice.

The recalled product

Product
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — MRI System
Hazard
  • implant-overheat
  • field-strength-overage

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: 9075653T
  • 2059953T
  • 2567373T
  • 251639MR3T
  • 334273CIC750W
  • 479571MANA
  • SMIDOB750W
  • 602863MR
  • 480265MR1
  • 480342MR3
  • SMIMCK750W
  • RADNETMR597
  • 530CHI750W
  • 840200DVMR1
  • 562869DVMR
  • 916V53TMR
  • 657293MR1
  • 949777MR1
  • 858824MR1
  • 858622HDMR1

Distribution

Distribution scope not specified by the agency.

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