The Recall Desk
HighFDA (Devices)·Z-2468-2024·Announced 2024-08-14

GE MR450w 1.5T MRI software defect may cause implant overheating

GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.

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 medical device with a real software defect that can cause thermal injury to MR-conditional implants, but no injuries have been reported. FDA Class II classification with no reported illnesses places this in the High (3) category per the severity rubric.

Plain-English summary

GE MR450w 1.5T MRI systems with affected software versions (DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1) contain a software defect that can cause the system's predicted radiofrequency (B1+RMS) value to exceed the user-prescribed safety limit when scanning in Low SAR Mode.

This defect occurs only when both of the following conditions are present: (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 MR system configuration. When these specific conditions occur, the radiofrequency miscalculation can result in overheating of MR-conditional implants, which may pose a risk to patients with such implants.

Approximately 1,607 units of the affected Optima MR450w 1.5T system have been distributed worldwide. Facilities operating affected MR systems should review their configurations and scan parameters to ensure compliance with prescribed limits. Patients with MR-conditional implants should inform their healthcare providers about this potential risk when undergoing MRI procedures. No injuries or illnesses have been reported to date.

The recalled product

Product
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging / MRI System
Hazard
  • software-defect
  • thermal-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 (20)

  • System ID: 907562450W
  • 907IAPMR1
  • 256ASURGMR1
  • 334826450W
  • 205991MR2
  • 205LMK450W
  • 205877450W
  • 205939450W
  • 205783450W
  • 205838MR4
  • 256840MR450W
  • 251621450W
  • 256973MR450
  • 334287MR
  • 251279MR1
  • 256571MR450W
  • 256737H450W
  • 205949MR450W
  • 256GMTMR450W
  • 256880MR1

Distribution

Distribution scope not specified by the agency.

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