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Ingenia 1.5T

by Philips Medical Systems Nederland B.V. Netherlands EUDAMEDGUDID

Ref 782140

Product code LNHEMDN Z11050104

Regulatory status

as of 25 Oct 2026

Recall ongoing. 39 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2243595CE01 Date24 Sep 2026IssuedStatusActive expires 1 May 2030
United StatesGUDID listing GUDID Number00884838108646 UDI-DIDate5 Oct 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    24 Sep 2026
    Expires
    1 May 2030
    Reason
    Add device or group

Recalls

39 recalls · 39 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-3318-2026 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
    • Ongoing Z-3314-2026 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-3243-2026 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
    • Ongoing Z-3235-2026 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.

  • 9 recalls, same reason

    • Ongoing Z-1955-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1968-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1960-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1966-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1956-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1954-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1969-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1961-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1967-2026 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.

  • 4 recalls, same reason

    • Ongoing Z-1215-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1210-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1205-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1204-2026 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).

  • 3 recalls, same reason

    • Ongoing Z-2209-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2208-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2204-2025 FDA Class II initiated 30 Jun 2025

    The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

  • 3 recalls, same reason

    • Ongoing Z-1795-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1798-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1801-2025 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.

  • 3 recalls, same reason

    • Ongoing Z-1950-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1949-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1948-2024 FDA Class II initiated 3 May 2024

    Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard

  • 2 recalls, same reason

    • Ongoing Z-1850-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1851-2024 FDA Class II initiated 3 May 2024

    The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

  • 4 recalls, same reason

    • Ongoing Z-1571-2024 FDA Class II initiated 12 Mar 2024
    • Ongoing Z-1569-2024 FDA Class II initiated 12 Mar 2024
    • Ongoing Z-1570-2024 FDA Class II initiated 12 Mar 2024
    • Ongoing Z-1568-2024 FDA Class II initiated 12 Mar 2024

    Patient support table floor plate may be incorrectly installed.

    • Ongoing Z-2397-2023 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.

    • Ongoing Z-2400-2023 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.

    • Ongoing Z-0715-2024 FDA Class II initiated 15 Jul 2021

    The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Ingenia 1.5T EUDAMED
Ingenia GUDID
Generic Name
Full-body MRI system, superconducting magnet
Device Name
Magnetic Resonance Imaging Systems
Model / Ref / Catalog
782140, Ingenia 1.5T
Primary DI / UDI-DI
00884838108646
Basic UDI-DI
0884838BM697TZ
Direct Marketing DI
00884838108646
FDA Product Code
LNH, LNI
EMDN Code
Z11050104 Closed magnet MRI scanners with magnetic field less than or equal to 2t
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1000
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
782140
GUDID
Ingenia 1.5T
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Related devices

Category: Full-body MRI system, superconducting magnet

Other devices from Philips Medical Systems Nederland B.V.

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

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED fea21691-e76c-49cb-b5ca-20c1869bee37 61 fields · synced 22 Oct 2026
  • FDA UDI ee583706-ad15-43cc-b829-45b8eba8b83a 35 fields · synced 30 May 2026