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HA FlexTrak

by Philips Medical Systems Nederland B.V. Netherlands EUDAMEDGUDID

Ref 989710006412

Product code LNHEMDN Z1105018099

Regulatory status

as of 24 Oct 2026

Recall ongoing. 39 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM474TB Basic UDI-DIDate31 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838099470 UDI-DIDate31 Aug 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: none listed in EUDAMED

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 via K213583, on the same 510(k)

    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.)

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
HA FlexTrak EUDAMED
Ingenia GUDID
Generic Name
Full-body MRI system, superconducting magnet
Device Name
Trolley, Acoustic Hood and Tabletop extender
Model / Ref / Catalog
989710006412, HA FlexTrak
Primary DI / UDI-DI
00884838099470
Basic UDI-DI
0884838BM474TB
Direct Marketing DI
00884838099470
FDA Product Code
LNH
EMDN Code
Z1105018099 Magnetic resonance (mr) systems - hardware accessories - other
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class I 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
989710006412
GUDID
HA FlexTrak
Device ClassEUDAMED
Class I
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 625601a0-0ed6-4884-9f18-68766dfe79af 61 fields · synced 22 Oct 2026
  • FDA UDI 6455a12a-f174-4929-b8d4-8786ce85d1f1 35 fields · synced 29 May 2026