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Ingenia 3.0T

by Philips Medical Systems Nederland B.V. Netherlands EUDAMEDGUDID

Ref 782103

Product code LNHEMDN Z11050105

Regulatory status

as of 25 Oct 2026

Recall ongoing. 100 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2243595CE01 Date24 Sep 2026IssuedStatusActive expires 1 May 2030
United StatesGUDID listing GUDID Number00884838098299 UDI-DIDate1 May 2021ListedStatusIn 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

100 recalls · 100 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-3314-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3309-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3311-2026 FDA Class II initiated 28 Aug 2026
    • Ongoing Z-3312-2026 FDA Class II initiated 28 Aug 2026
    • 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

    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.

  • 9 recalls, same reason

    • Ongoing Z-3243-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3241-2026 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
    • Ongoing Z-3239-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3237-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3233-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3238-2026 FDA Class II initiated 21 Aug 2026
    • Ongoing Z-3232-2026 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.

  • 12 recalls, same reason

    • Ongoing Z-1956-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1954-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1961-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1963-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1967-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1951-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1960-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1958-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1965-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1959-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1968-2026 FDA Class II initiated 14 Apr 2026
    • Ongoing Z-1953-2026 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.

  • 8 recalls, same reason

    • Ongoing Z-1208-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1210-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1206-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1209-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1204-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1212-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1211-2026 FDA Class II initiated 3 Dec 2025
    • Ongoing Z-1207-2026 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).

  • 11 recalls, same reason

    • Ongoing Z-2209-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2212-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2201-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2207-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2205-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2211-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2208-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2206-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2200-2025 FDA Class II initiated 30 Jun 2025
    • Ongoing Z-2210-2025 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.

  • 8 recalls, same reason

    • Ongoing Z-1933-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1932-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1929-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1931-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1930-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1928-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1934-2025 FDA Class II initiated 29 May 2025
    • Ongoing Z-1935-2025 FDA Class II initiated 29 May 2025

    identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

  • 9 recalls, same reason

    • Ongoing Z-1801-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1795-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1802-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1796-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1797-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1800-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1803-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1798-2025 FDA Class II initiated 13 May 2025
    • Ongoing Z-1799-2025 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.

  • 14 recalls, same reason

    • Ongoing Z-1780-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1783-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1777-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1773-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1778-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1771-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1770-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1776-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1775-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1772-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1782-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1774-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1779-2025 FDA Class II initiated 24 Mar 2025
    • Ongoing Z-1781-2025 FDA Class II initiated 24 Mar 2025

    The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

  • 13 recalls, same reason

    • Ongoing Z-3196-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3193-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3198-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3199-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3205-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3202-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3200-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3203-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3194-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3201-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3204-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3195-2024 FDA Class II initiated 3 Sep 2024
    • Ongoing Z-3197-2024 FDA Class II initiated 3 Sep 2024

    Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

  • 9 recalls, same reason

    • Ongoing Z-1853-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1839-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1850-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1849-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1847-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1852-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1845-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1838-2024 FDA Class II initiated 3 May 2024
    • Ongoing Z-1848-2024 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

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Ingenia 3.0T EUDAMED
Ingenia GUDID
Generic Name
Full-body MRI system, superconducting magnet
Device Name
Magnetic Resonance Imaging Systems
Model / Ref / Catalog
782103, Ingenia 3.0T
Primary DI / UDI-DI
00884838098299
Basic UDI-DI
0884838BM697TZ
Direct Marketing DI
00884838098299
FDA Product Code
LNH, LNI
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 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
782103
GUDID
Ingenia 3.0T
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

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 dd5a07d8-a8a5-4bf7-ba0d-96d2427d8308 61 fields · synced 22 Oct 2026
  • FDA UDI f62eff28-edf7-4c70-acf8-3c7fdfbe212c 35 fields · synced 30 May 2026