Z-0974-2024Class II

Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient...

Name: Z-0974-2024 Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient...
Creator: Philips North America
Published: 2022-01-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-01-06 / Open, Classified / root cause: design

FDA source

Philips North America began a recall of Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system on 2022-01-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0974-2024
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-06
Posted: 2024-02-02
Recalling firm: Philips North America LLC
Product: Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Beginning in January 2022, Philips Field Service Engineers (FSE) visited impacted customer sites to replace the magnetic castor wheels of the HA Flextrack Trolley II with non-magnetic castor wheels. All reachable systems were addressed as of August 10, 2023.
Quantity in commerce: 2
Distribution: Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
Product codes and lots: UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0973-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02
Z-0974-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02
Z-0975-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-02

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)