Philips North America: Ingenia MRI Patient Transportation Trolleys Recalled Due to Magnetic Wheels

Agency Publication Date: February 2, 2024

Summary

Philips North America is recalling 13 units of HA FlexTrak II patient transportation trolleys used with Ingenia 1.5T, Elition X, and Ambition X MRI systems. These trolleys were manufactured with magnetic material in the wheels, which can cause the trolley to be violently attracted to the MRI machine if it enters the magnetic field. This defect creates a serious hazard for patients being transported as well as medical staff in the vicinity. Consumers should contact the manufacturer immediately to address this safety issue.

Risk

The wheels of the trolley contain magnetic materials that can be pulled toward the powerful magnets of an MRI system, potentially leading to a collision, projectile hazard, or crushing injury for anyone nearby.

What You Should Do

Identify if your facility has an affected HA FlexTrak II patient transportation system by checking the Accessory Number 989710008732 and specific serial numbers.
For Ingenia 1.5T (Product 781396) users, check for Accessory Serial Number 100018 (associated with Ingenia Serial Number 41045).
For Ingenia Elition X (Product 781358) users, check for Accessory Serial Numbers 100029 or 100030 (associated with Ingenia Serial Number 45294).
For Ingenia Ambition X (Product 781356) users, check for Accessory Serial Numbers 100020, 100024, 100022, 100025, 100019, 100063, 100056, 100032, 100028, or 100031.
If you identify an affected unit, contact Philips North America at their Cambridge, MA headquarters or through your local service representative to receive instructions on remediation or replacement.
Contact your healthcare provider or the manufacturer for further instructions regarding the safety of these devices.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction via notification letter.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732)

Model / REF:

781396

989710008732

Lot Numbers:

Ingenia Serial 41045

Accessory Serial 100018

Product: Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732)

Model / REF:

781358

989710008732

Lot Numbers:

Ingenia Serial 45294

Accessory Serial 100029

Accessory Serial 100030

Product: Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732)

Model / REF:

781356

989710008732

Lot Numbers:

Ingenia Serial 47004 (Acc Serial 100020)

Ingenia Serial 47019 (Acc Serial 100024)

Ingenia Serial 47190 (Acc Serial 100022)

Ingenia Serial 47200 (Acc Serial 100025)

Ingenia Serial 47210 (Acc Serial 100019)

Ingenia Serial 47227 (Acc Serial 100063)

Ingenia Serial 47231 (Acc Serial 100056)

Ingenia Serial 47271 (Acc Serial 100032)

Ingenia Serial 47281 (Acc Serial 100028)

Ingenia Serial 47281 (Acc Serial 100031)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93737

Status: Active

Manufacturer: Philips North America

Sold By: Philips North America

Manufactured In: United States

Units Affected: 3 products (1; 2; 10)

Distributed To: Florida, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility has an affected HA FlexTrak II patient transportation system by checking the Accessory Number 989710008732 and specific serial numbers.

For Ingenia 1.5T (Product 781396) users, check for Accessory Serial Number 100018 (associated with Ingenia Serial Number 41045).

For Ingenia Elition X (Product 781358) users, check for Accessory Serial Numbers 100029 or 100030 (associated with Ingenia Serial Number 45294).

For Ingenia Ambition X (Product 781356) users, check for Accessory Serial Numbers 100020, 100024, 100022, 100025, 100019, 100063, 100056, 100032, 100028, or 100031.

If you identify an affected unit, contact Philips North America at their Cambridge, MA headquarters or through your local service representative to receive instructions on remediation or replacement.

Contact your healthcare provider or the manufacturer for further instructions regarding the safety of these devices.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732)

Model / REF:

781396

989710008732

Lot Numbers:

Ingenia Serial 41045

Accessory Serial 100018

Product: Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732)

Model / REF:

781358

989710008732

Lot Numbers:

Ingenia Serial 45294

Accessory Serial 100029

Accessory Serial 100030

Product: Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732)

Model / REF:

781356

989710008732

Lot Numbers:

Ingenia Serial 47004 (Acc Serial 100020)

Ingenia Serial 47019 (Acc Serial 100024)

Ingenia Serial 47190 (Acc Serial 100022)

Ingenia Serial 47200 (Acc Serial 100025)

Ingenia Serial 47210 (Acc Serial 100019)

Ingenia Serial 47227 (Acc Serial 100063)

Ingenia Serial 47231 (Acc Serial 100056)

Ingenia Serial 47271 (Acc Serial 100032)

Ingenia Serial 47281 (Acc Serial 100028)

Ingenia Serial 47281 (Acc Serial 100031)