SIGNA Premier

• • Ongoing Z-1767-2026 FDA Class II ·initiated 27 Feb 2026

  Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

• • Ongoing Z-2304-2025 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-2462-2024 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.

• • Ongoing Z-1430-2022 FDA Class II ·initiated 24 Jun 2022

  Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

• • Ongoing Z-0590-2022 FDA Class II ·initiated 23 Dec 2021

  The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

• • Ongoing Z-2052-2021 FDA Class II ·initiated 4 Jun 2021

  GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

• • Terminated Z-0132-2022 FDA Class II ·initiated 26 Aug 2021

  Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

510(k) Number

K193282 ↗

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

• SIGNA Hero Open recall

  Class II

  CE/MDR FDA 510(k) K213668 Active Cleared 20 Jan 2022

• Ready View

  Class II

  FDA 510(k) K110573 Active Cleared 3 May 2011

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

• What specialties and types of imaging can the SIGNA Premier MRI system support in clinical practice?

  The SIGNA Premier is designed for detailed anatomical and functional imaging across multiple specialties, including neuroscience, oncology, cardiac, musculoskeletal, and body imaging. Its advanced gradient and radiofrequency technology, along with specialized reconstruction algorithms, enhance image quality and speed, making it versatile for a wide range of diagnostic needs.

• Is the SIGNA Premier MRI system intended for single-use or reusable applications, and what does that mean for maintenance?

  The SIGNA Premier is supplied as a reusable, non-sterile device, meaning it is built for repeated use in clinical or research settings. This requires proper cleaning, calibration, and maintenance protocols to ensure consistent performance and compliance with regulatory standards. Reusability also implies that institutions must factor in operational costs for servicing and upkeep.

• What is the bore size of the SIGNA Premier MRI system, and how might this affect patient comfort and accessibility?

  The SIGNA Premier features a wide-bore design with a 70 cm opening, which generally provides greater patient comfort compared to narrower bore systems. This larger diameter can accommodate more patients, including those with larger body sizes or mobility limitations, while also reducing the likelihood of claustrophobia during scans.

• How is the regulatory compliance of the SIGNA Premier MRI system established, and what does this mean for buyers?

  The SIGNA Premier holds FDA 510(k) clearance under the Traditional pathway (K193282) and complies with EU MDR (Medical Device Regulation). This means it has undergone rigorous review by regulatory bodies to demonstrate substantial equivalence to predicate devices (for FDA) and meets EU safety, performance, and traceability requirements. Buyers should verify local regulatory requirements and ensure their facility’s infrastructure aligns with the system’s operational needs.

• What technologies does the SIGNA Premier incorporate to improve imaging performance, and how might these benefit clinicians?

  The SIGNA Premier integrates SuperG gradients, a 146-channel TDI architecture, and advanced reconstruction algorithms to enhance image clarity, speed, and detail. These features reduce scan times, improve resolution for complex anatomies, and enable faster workflows—particularly valuable in high-volume or specialized imaging settings like oncology or cardiac diagnostics.