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Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

by Philips Medical Systems Nederland B.V.

510(k) K183063

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

25 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK183063 Date14 Feb 2019ClearedStatusActive

Recalls

25 recalls · 25 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-3309-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3310-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3308-2026 FDA Class II initiated 28 Aug 2026

    When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

  • 4 recalls, same reason

    • Ongoing Z-3239-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3238-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3237-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3236-2026 FDA Class II initiated 21 Aug 2026

    A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

  • 3 recalls, same reason

    • Ongoing Z-1956-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1957-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1965-2026 FDA Class II initiated 14 Apr 2026

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    • Ongoing Z-1216-2026 FDA Class II initiated 3 Dec 2025

    The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

  • 4 recalls, same reason

    • Ongoing Z-1788-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1789-2025 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.

  • 2 recalls, same reason

    • Ongoing Z-2396-2023 FDA Class II initiated 12 Jun 2023
    • Ongoing Z-2395-2023 FDA Class II initiated 12 Jun 2023

    The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

  • 2 recalls, same reason

    • Ongoing Z-2398-2023 FDA Class II initiated 12 Jun 2023
    • Ongoing Z-2399-2023 FDA Class II initiated 12 Jun 2023

    During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

  • 5 recalls, same reason

    • Ongoing Z-0459-2023 FDA Class II initiated 22 Nov 2022
    • Ongoing Z-0460-2023 FDA Class II initiated 22 Nov 2022
    • Ongoing Z-0461-2023 FDA Class II initiated 22 Nov 2022
    • Ongoing Z-0463-2023 FDA Class II initiated 22 Nov 2022
    • Ongoing Z-0462-2023 FDA Class II initiated 22 Nov 2022

    Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

    • Ongoing Z-0975-2024 FDA Class II initiated 6 Jan 2022

    Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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