The Recall Desk
HighFDA (Devices)·Z-2463-2024·Announced 2024-08-14

GE SIGNA HDxt 3.0T MRI systems may overheat implanted devices

GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.

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 involving a device software issue that can expose patients with implanted devices to excessive radiofrequency energy. The source text does not report any actual injuries or incidents, indicating a theoretical risk rather than confirmed harm. Per the rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

GE Medical Systems, LLC is recalling 3.0T SIGNA HDxt Family MRI systems containing certain software versions due to a radiofrequency energy safety issue. The affected software versions are RX27.0 through RX27.3, RX28.0, RX29.0 through RX29.2, MR30.0, MR30.1, HD16.0_V03, and HD23.0_V03, with worldwide distribution.

The problem occurs when the following two conditions are met simultaneously: the operator selects a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence while the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration. When scanning in Low SAR Mode, these conditions can cause the B1+RMS (radiofrequency energy intensity) to exceed the prescribed safety limit.

Excessive radiofrequency exposure can result in overheating of MR-conditional implanted medical devices—medical devices that have been tested and approved for use in MRI scanners under established safety conditions. Patients who have such implants may be at risk if exposed to excessive radiofrequency energy during imaging scans.

No injuries or incidents have been reported to date.

The recalled product

Product
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Imaging Equipment
Hazard

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: 907562P3T
  • 205939MR4
  • 2059393T
  • 256734MR3T
  • 623879MR1
  • 623433MR1
  • 928213MR3T
  • 928223MR3T
  • 480584MR1
  • RADNETMR656
  • 602588CMR1
  • RADNETMR670
  • 602689MR1
  • SMIGDYMR1
  • 9287573TMR
  • 480464MR1
  • RADNETMR669
  • 480324MR1
  • 4809643TMR
  • 954SIMON3T

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 · radiofrequency overexposure

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