The Recall Desk
HighFDA (Devices)·Z-2464-2024·Announced 2024-08-14

GE Discovery MR750 MRI System Software May Cause Implant Overheating

GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking 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 recall involves a specific software condition that can cause overheating of MR-conditional patient implants. As an FDA Class II recall with no reported injuries and a hazard that is contingent on multiple specific conditions being present simultaneously, it meets the rubric criteria for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE HealthCare is recalling certain Discovery MR750 3.0T MRI systems due to a software condition that can cause elevated radiofrequency exposure in specific scanning scenarios. The affected systems use software versions DV24.0, DV25.0, DV25.1, DV26.0 through DV26.4, DV29.1, MR30.0, and MR30.1. An estimated 484 units have been distributed worldwide.

The software issue occurs when scanning in Low SAR Mode with 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences while the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration. Under these conditions, the system's predicted B1+RMS radiofrequency field value can exceed the user-prescribed safety limit.

For patients with MR-conditional implants, this condition poses a risk of implant overheating from excessive radiofrequency exposure. The elevated field exposure occurs only when both the specific imaging sequence and configuration conditions are simultaneously present.

Healthcare providers should contact GE HealthCare to verify whether their MRI systems are affected by these software versions and to obtain necessary updates or mitigation measures.

The recalled product

Product
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — MRI System
Hazard
  • radiofrequency-overexposure
  • implant-overheating

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: 205592450W
  • 205592750
  • BMDACCMR1
  • 480425MR6
  • 623SMCSMR
  • 602839MR1
  • 602RITMR
  • 480768MR2
  • RADNETMR644
  • UCB3TMR
  • 3106573TMR
  • 650PH3T
  • 760SMCBMR
  • 510537MR750
  • 559325CIIMR3
  • 858822HDMR3
  • 858822HDMR1
  • 209225VC750
  • ASLW750
  • 415723CHMR3

Distribution

Distribution scope not specified by the agency.

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