FDAClass IIFebruary 14, 2024

Ingenia Elition X recall

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

Why was Ingenia Elition X 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030

Product
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Recalling firm
Philips North America
Quantity
2
Distribution
Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
Recall date
February 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls