Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

• 4 recalls, same reason

  • Ongoing Z-1789-2025 FDA Class II ·initiated 13 May 2025
  • Ongoing Z-1788-2025 FDA Class II ·initiated 13 May 2025
  • Ongoing Z-1791-2025 FDA Class II ·initiated 13 May 2025
  • Ongoing Z-1790-2025 FDA Class II ·initiated 13 May 2025

  Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

• 5 recalls, same reason

  • Ongoing Z-0389-2024 FDA Class II ·initiated 23 Oct 2023
  • Ongoing Z-0390-2024 FDA Class II ·initiated 23 Oct 2023
  • Ongoing Z-0393-2024 FDA Class II ·initiated 23 Oct 2023
  • Ongoing Z-0394-2024 FDA Class II ·initiated 23 Oct 2023
  • Ongoing Z-0392-2024 FDA Class II ·initiated 23 Oct 2023

  Potential component failure in the Gradient Coil could product smoke and/or fire.

• 5 recalls, same reason

  • Completed Z-2420-2021 FDA Class II ·initiated 11 Aug 2021
  • Completed Z-2415-2021 FDA Class II ·initiated 11 Aug 2021
  • Completed Z-2414-2021 FDA Class II ·initiated 11 Aug 2021
  • Completed Z-2421-2021 FDA Class II ·initiated 11 Aug 2021
  • Completed Z-2412-2021 FDA Class II ·initiated 11 Aug 2021

  When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

• 2 recalls, same reason

  • Terminated Z-2341-2021 FDA Class II ·initiated 30 Jul 2021
  • Terminated Z-2345-2021 FDA Class II ·initiated 30 Jul 2021

  Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

• 3 recalls, same reason

  • Terminated Z-0901-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0902-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0904-2019 FDA Class II ·initiated 21 Dec 2018

  There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

• 2 recalls, same reason

  • Terminated Z-1436-2018 FDA Class II ·initiated 16 Mar 2018
  • Terminated Z-1437-2018 FDA Class II ·initiated 16 Mar 2018

  Potential risk for helium gas inside the MR examination room during a magnet quench

510(k) Number

K162931 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Azurion upgrade to R4

  Class IIb

  CE/MDR

• Marlin 1.5T

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030

• Zenition 30

  Class II

  FDA 510(k) K254205 Active Cleared 7 Aug 2026

• dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

  Class II

  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

See all devices from Philips Medical Systems Nederland B.V. →

• What types of clinical environments are the Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems intended for, and why?

  The Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems are specifically designed for use in radiology departments. This is because they utilize nuclear magnetic resonance technology to generate detailed images of internal body structures, enabling precise diagnostic evaluations. The systems require strict adherence to MRI safety protocols, which are typically enforced in specialized radiology settings.

• Are the Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems single-use or reusable, and what does that mean for maintenance?

  The Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems are not single-use devices—they are reusable medical equipment. This means they require regular maintenance, calibration, and servicing to ensure optimal performance, safety, and compliance with regulatory standards over their operational lifespan.

• What regulatory pathways have the Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems followed, and what does that imply for their use?

  The Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems have been authorized through FDA 510(k) and MDR (Medical Device Regulation) pathways. This implies they meet regulatory standards for nuclear magnetic resonance imaging systems and are classified under device class II, requiring compliance with safety, performance, and quality management systems as outlined in these frameworks.

• How do the Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems differ in terms of field strength, and what does that mean for imaging capabilities?

  The Ingenia systems come in two field strengths: 1.5T (Tesla) and 3.0T (Tesla). Higher field strength (3.0T) generally provides superior image resolution and contrast, enabling more detailed visualization of soft tissues and smaller structures, which can be particularly useful for complex diagnostic evaluations. The 1.5T model offers a balance between image quality and accessibility, often preferred for broader clinical applications.

• What should buyers or facilities consider regarding the storage and handling of the Ingenia MRI systems?

  While the Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 MRI systems themselves are not single-use, their components or accessories may require careful handling. The systems are designed for radiology departments, so facilities must ensure proper installation in designated MRI-safe areas, away from incompatible materials (e.g., ferromagnetic objects). Regular maintenance and adherence to manufacturer guidelines are critical to preserve performance and safety, as these systems are not intended for casual or temporary use.