Philips Medical Systems Nederland B.V.: Imaging Systems Recalled Due to Foot Switch Sticking and Unintended Radiation

Agency Publication Date: September 7, 2023

Summary

Philips Medical Systems Nederland B.V. is recalling 16,296 medical imaging systems, including the Allura Xper series, Azurion series, and MultiDiagnost-Eleva models. The recall was initiated because the foot switch pedal can become stuck in the active position even after the user releases it. This defect causes the machines to continue emitting radiation unexpectedly, which could expose patients and medical staff to unnecessary radiation. These professional diagnostic systems were distributed nationwide across the United States.

Risk

A mechanical failure in the foot switch causes it to remain engaged, leading to the emission of unintended radiation. This poses a risk of radiation overexposure to both the patient undergoing the procedure and the healthcare professionals in the room.

What You Should Do

Identify if your facility uses the affected Philips imaging systems: Allura Xper series (Recall Z-2402-2023), Azurion series (Recall Z-2403-2023), or MultiDiagnost-Eleva (Recall Z-2404-2023).
Inspect the foot switch pedals for any signs of sticking or failure to return to the neutral position when released.
Contact Philips Medical Systems Nederland B.V. or your local Philips service representative to discuss the corrective actions and technical support provided in the notification letter sent on July 19, 2023.
If you are a patient, contact your healthcare provider if you have concerns about radiation exposure during a procedure involving these specific Philips systems.
For additional information or to report further issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for technical instructions.

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

Affected Products

Product: Allura Xper series

Model / REF:

Z-2402-2023

Lot Numbers:

Allura Xper series

Product: Azurion

Model / REF:

Z-2403-2023

Lot Numbers:

Azurion series

Product: MultiDiagnost-Eleva

Model / REF:

Z-2404-2023

Lot Numbers:

MultiDiagnost-Eleva

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92855

Status: Active

Manufacturer: Philips Medical Systems Nederland B.V.

Sold By: Philips Medical Systems; Medical device distributors

Manufactured In: Netherlands

Units Affected: 3 products (5432 systems in total)

Distributed To: Nationwide

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 uses the affected Philips imaging systems: Allura Xper series (Recall Z-2402-2023), Azurion series (Recall Z-2403-2023), or MultiDiagnost-Eleva (Recall Z-2404-2023).

Inspect the foot switch pedals for any signs of sticking or failure to return to the neutral position when released.

Contact Philips Medical Systems Nederland B.V. or your local Philips service representative to discuss the corrective actions and technical support provided in the notification letter sent on July 19, 2023.

If you are a patient, contact your healthcare provider if you have concerns about radiation exposure during a procedure involving these specific Philips systems.

For additional information or to report further issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.