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

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II recalled

Philips North America is recalling Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number, 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 00884838090040 Ingenia Serial number / Accessory Serial Number 47004 100020 47019 100024 47190 100022 47200 100025 47210 100019 47227 100063 47231 100056 47271 100032 47281 100028 47281 100031

Quantity recalled10

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-0975-2024
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 Ambition X (Product Number 781356) - 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 00884838090040 Ingenia Serial number / Accessory Serial Number 47004 100020 47019 100024 47190 100022 47200 100025 47210 100019 47227 100063 47231 100056 47271 100032 47281 100028 47281 100031

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

Reported	Class	Recall	Company	Reason	Where
14 Feb 2024	CLASS II	Ingenia 1.5T (Product Number 781396) - 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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