Agency classClass IIOur severity:High FDA (Devices)·Z-0973-2024·Announced 2024-02-14

Ingenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field

Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device without reported injuries or incidents. The magnetic wheels create a theoretical but significant hazard in MRI environments where unintended magnetic attraction could occur during patient transportation.

Plain-English summary

Philips North America is recalling the Ingenia 1.5T (Product Number 781396) with HA FlexTrak II trolley (Accessory Number 989710008732) patient transportation system. The recall is due to a hazard with the trolley wheels.

The trolley wheels contain magnetic materials that could be attracted to the magnetic field of MRI systems. If the trolley is positioned within an MRI system's magnetic field, the wheels may be attracted to it, potentially creating a hazard during patient transportation procedures.

The affected equipment has been distributed in the United States (Florida and New York) and internationally (Denmark, Norway, and Sweden). The recalled device with serial number Ingenia 41045 and Accessory Serial Number 100018 may be affected.

Users of the affected equipment should contact Philips North America for information about their equipment and available alternatives or remediation options.

The recalled product

Product: Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Manufacturer: Philips North America
Category: Medical Device — Imaging Equipment Accessory
Hazard: magnetic-attraction
patient-safety
Affected units: 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Philips North America

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Same hazard · magnetic attraction