SIGNA Hero

• • Ongoing Z-2308-2025 FDA Class II ·initiated 20 Jun 2025

  GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

• • Ongoing Z-2461-2024 FDA Class II ·initiated 14 Jun 2024

  GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 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 MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

510(k) Number

K213668 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T Open recall

  Class II

  FDA 510(k) K132376 Active Cleared 15 Nov 2013

• SIGNA Creator, SIGNA Explorer Open recall

  Class II

  FDA 510(k) K143251 Active Cleared 4 Feb 2015

• Optima MR450W

  Class II

  FDA 510(k) K123522 Active Cleared 13 Mar 2013

• SIGNA Architect Open recall

  Class II

  CE/MDR FDA 510(k) K202966 Active Cleared 13 Nov 2020 +1authorizations

• Ready View

  Class II

  FDA 510(k) K110573 Active Cleared 3 May 2011

• SIGNA Premier Open recall

  Class II

  CE/MDR FDA 510(k) K193282 Active Cleared 10 Apr 2020

See all devices from Ge Healthcare (Ge Medical Systems, LLC) →

• What types of medical facilities can use the SIGNA Hero MRI system, and why is it suitable for them?

  The SIGNA Hero is designed for use in radiology departments and clinical imaging centers. It is suitable for these facilities because it provides high-field magnetic resonance imaging, enabling detailed cross-sectional imaging of soft tissues, organs, and musculoskeletal systems with high contrast resolution. This makes it ideal for comprehensive diagnostic evaluations in specialized medical environments.

• Is the SIGNA Hero MRI system single-use or reusable, and what does this mean for maintenance and cleaning?

  The SIGNA Hero is a reusable MRI system, meaning it is not intended for single-use. As a reusable device, it requires regular maintenance and cleaning according to the manufacturer’s guidelines to ensure consistent performance, safety, and longevity. Proper care is essential to maintain imaging quality and compliance with regulatory standards.

• What regulatory pathways has the SIGNA Hero MRI system followed, and how does this affect its global availability?

  The SIGNA Hero has received FDA 510(k) clearance (K213668) and EU MDR compliance, along with multiple registration numbers for global markets. These pathways ensure the device meets stringent regulatory requirements in the United States and European Union, facilitating its availability in radiology departments worldwide while adhering to local health authority standards.

• How should the SIGNA Hero MRI system be stored, and are there any specific environmental requirements?

  The SIGNA Hero must be stored and maintained following the manufacturer’s guidelines to ensure optimal performance and safety. While the data does not specify exact environmental conditions, typical MRI systems require protection from extreme temperatures, humidity, and physical damage. Proper storage also includes securing the device in a dedicated, stable location to prevent interference with its magnetic field or mechanical components.

• What types of accessories are compatible with the SIGNA Hero, and how does this impact clinical workflows?

  The SIGNA Hero is designed to be compatible with MRI-safe accessories, which means it can integrate with a range of imaging tools, coils, and patient positioning aids that do not interfere with its magnetic field. This compatibility enhances clinical flexibility, allowing radiologists to use specialized equipment for different diagnostic needs—such as cardiac, neurological, or musculoskeletal imaging—while maintaining safety and image quality.