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Ingenia Elition S and Ingenia Elition X R5.4

by Philips Medical Systems Nederland B.V.

510(k) K173356

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 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 NumberK173356 Date6 Mar 2018ClearedStatusActive

Recalls

13 recalls · 10 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2395-2023 FDA Class II initiated 12 Jun 2023
    • Ongoing Z-2396-2023 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-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
    • Ongoing Z-0459-2023 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-0974-2024 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.

  • 2 recalls, same reason

    • Terminated Z-0922-2019 FDA Class II initiated 21 Dec 2018
    • Terminated Z-0923-2019 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.

    • Terminated Z-0694-2019 FDA Class II initiated 3 Dec 2018

    During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

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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