The Recall Desk
HighFDA (Devices)·Z-2473-2024·Announced 2024-08-14

MR System Software Defect May Cause Implant Overheating During Scanning

GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.

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 Class II recall involving potential implant overheating during MR scanning under specific sequence and configuration conditions. No illnesses have been reported, but the hazard presents risk of harm to patients with implants.

Plain-English summary

The recall involves GE Medical Systems SIGNA Explorer MR (magnetic resonance) imaging systems with software versions SV25.5, SV25.6, SV29.2, MR30.0, or MR30.1 distributed worldwide. During Low SAR Mode scanning, the system's predicted radiofrequency absorption rate (B1+RMS value) can exceed the user-prescribed limit under specific conditions.

The problem occurs when two conditions are both 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 device configuration. When both occur, the MR system can overheat MR-conditional implants, including pacemakers and other magnetically sensitive medical devices.

Approximately 2,528 units have been distributed. No injuries or illnesses have been reported to date. Patients with MR-conditional implants should contact their healthcare provider or GE HealthCare to determine if their system is affected and discuss appropriate next steps.

The recalled product

Product
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — MR Imaging System
Hazard
Affected units
2,528

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: K2308
  • SHIMR02644
  • 415723SHMR6
  • 951682MR
  • 619291MR1
  • 2533
  • 303355MR
  • 305682MR1
  • 727869MR
  • 352344MR2
  • 407PIMRKCH
  • 630332MR
  • 316689MR
  • 508746JMR2
  • 406863WMR
  • 445MR2
  • 718567MR
  • 718250MR
  • 716839MR1
  • MSF094-1-6UQ9H2TJ

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 →

Related recalls

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Same hazard · implant overheating

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