The Recall Desk
HighFDA (Devices)·Z-2466-2024·Announced 2024-08-14

SIGNA PET/MR diagnostic imaging system poses implant overheating risk

GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.

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 risk-of-harm product (implant overheating) without reported injury or hospitalization, fitting the High severity criterion. Although classified as FDA Class II, the absence of reported incidents combined with the conditional nature of the hazard (requiring specific imaging parameters) places this at severity level 3.

Plain-English summary

GE HealthCare is recalling 123 units of SIGNA PET/MR diagnostic imaging systems with software versions MP24.0, MP26.0, MP26.1, MR30.0, and MR30.1. Under certain conditions, the system can exceed user-prescribed radiofrequency (RF) energy limits, potentially causing overheating of MR-conditional implants (implantable medical devices such as pacemakers approved for use in MR environments).

The problem occurs when the system operates in Low SAR Mode and both of the following conditions are met: (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 system configuration.

The affected systems were distributed worldwide. This recall affects healthcare facilities and clinics operating these system versions, particularly those performing MR imaging on patients with MR-conditional implants.

The recalled product

Product
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging / MRI-PET System
Hazard
Affected units
123

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: UABMRPET
  • 480342PETMR1
  • 415493VMR4
  • 415723CHMR6
  • 415CBMRPWS
  • 415CBMRP
  • 415723SHMR15
  • 415723SHWS15
  • 415723SHMRW
  • 720482PETMR
  • DUPONTPETMR
  • 904953PMR3T
  • 404778PETMR
  • 617726PETMR
  • 301496PETMR
  • MAYOPETMR01
  • WCIDHKMR1
  • MSK68MR01
  • 914681MR3T
  • 503418PETMR

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 →

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