The Recall Desk
HighFDA (Devices)·Z-2480-2024·Announced 2024-08-14

MRI System Software Issue Can Overheat Implanted Medical Devices

GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.

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 an FDA Class II device recall involving potential thermal injury to implanted medical devices. The source reports no injuries, illnesses, or deaths. Per the rubric, this qualifies as High (Score 3) because it represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE HealthCare recalled 23 SIGNA Victor MRI systems with software version MR30.1, which were distributed worldwide.

The systems have a software defect affecting how radiofrequency energy is calculated and limited. Under specific conditions—when the system operates in Low SAR Mode with a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence AND the Optimized T2 FLAIR sequence option is disabled or absent—the predicted B1+RMS radiofrequency energy value can exceed the user-prescribed safety limit. This can result in overheating of MR conditional implants, which are surgically implanted medical devices with specific MRI compatibility restrictions.

Patients with MR conditional implants who undergo MRI scans on the affected systems may be at risk if the system settings match the problematic combination described in the recall.

The recalled product

Product
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — MRI Imaging 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: GON5374156
  • DZ4952MR01
  • MRPM1180
  • MRR8022
  • MRPM0474A
  • MRPM1267
  • MRR8322
  • MRPM0795
  • MRPM1093
  • FI1271MR01
  • XM9192701
  • MR53305381
  • 397480MR01
  • PC7479MR04
  • H6383MR02
  • MR00226
  • MR00207
  • 1553MR0071
  • PPS79502
  • SA2215MR01

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

Same manufacturer · GE Medical Systems, LLC

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Same hazard · implant overheating

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