CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II recalled

Philips North America is recalling Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), distributed nationwide in the US. The recall was initiated on 6 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00884838009820 Ingenia Serial number 41045 Accessory Serial Number 100018

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0973-2024
FDA event ID: 93737
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Jan 2022
FDA classified: 2 Feb 2024
Reported: 14 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Jan 2022	Recall initiated by company
2 Feb 2024	Classified by FDA	+757 days
14 Feb 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Where it was distributed

Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.

Nationwide Florida New York

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

UDI-DI 00884838009820 Ingenia Serial number 41045 Accessory Serial Number 100018

Where was it sold?

Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 93737

This product is part of a recall event; the main page for the event is Ingenia Ambition X (Product Number 781356) - HA FlexTrak II recalled.

Reported	Class	Recall	Company	Reason	Where
14 Feb 2024	CLASS II	Ingenia Ambition X (Product Number 781356) - HA FlexTrak II recalled	Philips North America	Other	Nationwide
14 Feb 2024	CLASS II	Ingenia Elition X (Product Number 781358) - HA FlexTrak II recalled	Philips North America	Other	Nationwide

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