The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2467-2024·Announced 2024-08-14

Discovery MR450 MRI System Can Overheat Implants Under Specific Conditions

GE Discovery MR450 MRI systems with certain software versions can cause implant overheating under specific scanning conditions. 23 units worldwide require firmware updates.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall involving potential overheating of MR conditional implants, a serious risk-of-harm scenario. No illnesses, hospitalizations, or injuries are reported in the source, making the hazard theoretical rather than demonstrated.

Plain-English summary

GE Medical Systems is recalling Discovery MR450 1.5T MRI systems with software versions DV24.0, DV25.0, DV25.1, and DV26.0 due to a potential overheating hazard affecting MR conditional implants.

The affected systems can generate higher radiofrequency (B1+RMS) energy than the user-prescribed limit when operating in Low SAR Mode under specific scanning conditions: using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences with the Optimized T2 FLAIR feature disabled or not included in the system configuration.

A total of 23 units have been distributed worldwide. GE HealthCare recommends that medical facilities using affected systems review their MRI protocols and configurations, particularly for patients with MR conditional implants. Users should update to unaffected software versions and verify their T2 FLAIR sequence configurations to prevent potential implant heating during scanning.

The recalled product

Product
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Imaging / MRI System
Hazard
Affected units
23

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: 714957MR
  • 209225VC450
  • 858939MR4
  • 858939MR3
  • 202476MR1
  • HSS75MR450
  • HSSMAGNETF
  • 713566SMITH3
  • 713566SMITH1
  • 832522MR2
  • 920830MR450
  • 304256MR2
  • 250727MR2
  • DK1083MR06
  • FI1052MR01
  • RMUE01MR04
  • A5624132
  • D5354206
  • SA1058MR02
  • SA1011MR03

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 26 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

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