The Recall Desk
HighFDA (Devices)·Z-2478-2024·Announced 2024-08-14

GE Optima MR360 MRI System Software May Overheat Implants

GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are 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: FDA Class II recall of a risk-of-harm medical device where no injuries or illnesses have been reported. The hazard—implant overheating from excessive radiofrequency energy—is genuine and could cause patient harm, but it requires specific concurrent technical conditions and has not resulted in reported incidents.

Plain-English summary

GE Medical Systems is recalling Optima MR360 MRI systems containing software versions SV20.3, SV23.3, MR30.0, or MR30.1 distributed worldwide. The systems can exceed safe radiofrequency (B1+RMS) energy limits during certain scanning conditions, potentially overheating MR-conditional implants in patients.

The issue occurs when Low SAR Mode is used with two concurrent conditions: a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected, and the Optimized T2 FLAIR option is turned off or absent from the system configuration. When both conditions are met, the system may deliver radiofrequency energy above the user-prescribed safety limit.

The recall affects 469 units distributed globally. The hazard poses a specific risk to patients who have MR-conditional implants (such as cardiac pacemakers, defibrillators, or neurostimulators) and require MRI scans using these sequences. Affected healthcare facilities should verify their system software version and either implement a software update to a non-affected version or modify imaging protocols to avoid the hazardous sequence-configuration combination.

The recalled product

Product
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Magnetic Resonance Imaging
Hazard
Affected units
469

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: 1009000
  • 201871MR
  • DZ1396MR01
  • DZ1820MR01
  • DZ1339MR02
  • DZ1339MR01
  • DZ1061MR01
  • DZ1406MR01
  • DZ1285MR01
  • DZ1191MR01
  • 0910272060
  • 0910274038
  • 0910274036
  • BH1038MR01
  • MRR9112
  • MRR10326
  • MRR8777
  • MRR10248
  • MRR9308
  • MRR10649

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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