The Recall Desk
HighFDA (Devices)·Z-2461-2024·Announced 2024-08-14

MRI System Software Miscalculation May Overheat Patient Implants

A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed 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 with no reported illnesses or injuries. The hazard is potential overheating of MR conditional implants—a risk-of-harm scenario where injury has not yet been reported, qualifying as 'High' severity per the established rubric.

Plain-English summary

GE HealthCare has recalled the SIGNA Hero nuclear magnetic resonance imaging system due to a software error. The recall affects 95 units distributed worldwide, including systems running software versions PX29.1, MR30.0, and MR30.1.

Under specific operating conditions—when the system is in Low SAR Mode, a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected, and the Optimized T2 FLAIR sequence option is either off or not included in the configuration—the system's software can incorrectly exceed the operator's prescribed B1+RMS radiofrequency limit. This can result in overheating of MR conditional implants used in patients.

No injuries or illnesses have been reported. Healthcare facilities operating these systems should contact GE HealthCare for guidance on corrective action and potential software updates.

The recalled product

Product
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Medical Imaging Equipment
Hazard
Affected units
96

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: 501225HEROMR3
  • 480425MR12
  • RADNETMR665
  • 719293MR
  • 719505MR
  • RISMR
  • 678604PHMR
  • 217258SBMR3T
  • 508258MR
  • 406327AMR2
  • 336760MR2
  • 402AMI3T
  • 585922HEROMR
  • 405601MR2
  • 843MSEA3T
  • 713SIGNAHERO1
  • RADNETMR677
  • 903758MR3T
  • 713442KSMR7
  • 713442FTBNDMR2

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

See all →

Same hazard · software miscalculation

See all →