SIGNA Architect

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• 5 recalls, same reason

  • Ongoing Z-2303-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2302-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2306-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2299-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2301-2025 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-2130-2025 FDA Class II ·initiated 23 May 2025

  GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

• 3 recalls, same reason

  • Ongoing Z-0517-2025 FDA Class II ·initiated 28 Oct 2024
  • Ongoing Z-0518-2025 FDA Class II ·initiated 28 Oct 2024
  • Ongoing Z-0519-2025 FDA Class II ·initiated 28 Oct 2024

  Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

• 6 recalls, same reason

  • Ongoing Z-2468-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2464-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2467-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2465-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2469-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2459-2024 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.

• 5 recalls, same reason

  • Ongoing Z-0594-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0600-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0602-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0591-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0593-2022 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.

• 6 recalls, same reason

  • Ongoing Z-2061-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2055-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2064-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2056-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2053-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2063-2021 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.

• 5 recalls, same reason

  • Terminated Z-0133-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0136-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0139-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0140-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0135-2022 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.

• 4 recalls, same reason

  • Terminated Z-0129-2021 FDA Class II ·initiated 8 Sep 2020
  • Terminated Z-0130-2021 FDA Class II ·initiated 8 Sep 2020
  • Terminated Z-0128-2021 FDA Class II ·initiated 8 Sep 2020
  • Terminated Z-0127-2021 FDA Class II ·initiated 8 Sep 2020

  Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

• • Terminated Z-0875-2020 FDA Class II ·initiated 23 Dec 2019

  It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

Generic Name

Full-body MRI system, superconducting magnet

Model / Reference

SIGNA Architect

Primary DI / UDI-DI

00195278023643

Basic UDI-DI

8406821BUG00003GJ

510(k) Number

K202966 ↗ 510(k)

K163331 ↗ GUDID

FDA Product Code

LNH

EMDN Code

Z11050105 Closed magnet MRI scanners with magnetic field greater than 2t and less than or equal to 4t

GMDN Term

Full-body MRI system, superconducting magnet

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1000

EU market of registration

France

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• 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 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

• 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 conditions can the SIGNA Architect help diagnose, and how does it achieve this?

  The SIGNA Architect is designed to generate detailed images of soft tissues, organs, and skeletal structures using strong magnetic fields and radio waves. This enables diagnostic evaluation for conditions such as tumors, vascular diseases, and musculoskeletal disorders by providing high-resolution images that help radiologists assess internal body structures.

• Is the SIGNA Architect a single-use device, or is it intended for reuse in a clinical setting?

  The SIGNA Architect is supplied as a reusable system, meaning it is intended for long-term use in radiology departments. Like all MRI systems, it requires regular maintenance, calibration, and adherence to MRI safety protocols to ensure proper functionality and compliance with magnetic field strength guidelines.

• What regulatory pathways has the SIGNA Architect followed, and what does this mean for its use in clinical settings?

  The SIGNA Architect has been authorized through FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and performance. This classification as a Class II medical device under product code LNH and regulation number 892.1000 ensures it is intended for use in radiology departments by trained radiologic technologists and interpreted by radiologists, adhering to strict quality and safety requirements.

• How is the SIGNA Architect maintained to ensure MRI safety compliance, and who is responsible for this?

  The SIGNA Architect requires proper maintenance and calibration to ensure MRI safety compliance, including compatibility with MRI environments and adherence to magnetic field strength guidelines. This responsibility lies with trained radiologic technologists and facility staff, who must follow manufacturer protocols and regulatory standards to maintain optimal performance and safety.