PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper and Azurion Systems Recalled for Imaging Failure Risk

Agency Publication Date: February 16, 2024

Summary

Philips Medical Systems is recalling approximately 13,133 Allura Xper and Azurion Interventional Fluoroscopic X-ray systems because the Disk Bay component in the system's computers may malfunction. This defect can cause the imaging system to stop working entirely during a medical procedure, which prevents doctors from seeing the images they need to treat patients. This recall affects various models of the Allura Xper and Azurion lines distributed globally, including 3,408 units across nearly every U.S. state. While no specific injuries are mentioned in this data, the failure can cause serious delays in critical surgical or interventional procedures.

Risk

If the Disk Bay fails during a procedure, the system will stop functioning and live imaging will become impossible. This forces medical staff to stop or delay the procedure, which could lead to complications for patients currently undergoing treatment or surgery.

What You Should Do

Identify if your facility uses Philips Allura Xper (Models FD10, FD20, FD10/10, etc.) or Azurion (Models 3 M12, 5 M20, 7 B12, etc.) systems by checking the model and serial numbers on the PC components.
For Allura Xper systems, locate the Imaging Processing PC, Host PC, or FlexVision PC; for Azurion systems, locate the XRay PC, Suite PC, or FlexViewing PC to verify identifying information.
Verify your serial number against the extensive list provided in the recall notice, specifically checking for UDI-DI codes such as 00884838059030 (Allura) or 00884838085275 (Azurion).
Immediately contact your Philips service representative or Philips Medical Systems Nederland B.V. to schedule an inspection and potential repair of the computer's Disk Bay.
If the system fails during a procedure, follow your facility's emergency protocols for equipment failure to ensure patient safety.
For further information or technical guidance, contact Philips Medical Systems at their Netherlands headquarters or your local authorized distributor.
Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding this safety recall.

Your Remedy Options

Other Action

Manufacturer communication and investigation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential remedy regarding the disk bay failure.

Affected Products

Product: Philips Allura Xper Interventional Fluoroscopic X-ray Systems

Model / REF:

722003

722010

722026

722022

722005

722011

722027

722001

722006

722012

722028

722008

722013

722025

722023

722035

722029

722058

722059

722038

722039

Lot Numbers:

UDI-DI 00884838059030

UDI-DI 00884838059191

UDI-DI 00884838054189

UDI-DI 00884838080805

UDI-DI 00884838054196

UDI-DI 00884838059115

UDI-DI 00884838059054

UDI-DI 00884838059207

UDI-DI 00884838054202

UDI-DI 00884838059269

UDI-DI 00884838059061

UDI-DI 00884838059085

UDI-DI 00884838054240

UDI-DI 00884838054219

UDI-DI 00884838059122

UDI-DI 00884838054226

Product: Philips Azurion Interventional Fluoroscopic X-ray Systems

Model / REF:

722063

722221

722064

722222

722228

722067

722225

722068

722226

722078

722223

722079

722224

Lot Numbers:

UDI-DI 00884838085275

UDI-DI 00884838086777

UDI-DI 00884838099203

UDI-DI 00884838085282

UDI-DI 00884838099210

UDI-DI 00884838099234

UDI-DI 00884838059290

UDI-DI 00884838064775

UDI-DI 00884838085350

UDI-DI 00884838099265

UDI-DI 00884838059207

UDI-DI 00884838085367

UDI-DI 00884838101883

UDI-DI 00884838099272

UDI-DI 00884838085251

UDI-DI 00884838101890

UDI-DI 00884838099241

UDI-DI 00884838059221

UDI-DI 00884838085268

UDI-DI 00884838059184

UDI-DI 00884838099258

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93781

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Philips Medical Systems Nederland B.V.; Authorized Medical Device Distributors

Manufactured In: Netherlands

Units Affected: 2 products (13, 133 (3,408 US; 9,725 ROW))

Distributed To: Alabama, Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

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 Philips Allura Xper (Models FD10, FD20, FD10/10, etc.) or Azurion (Models 3 M12, 5 M20, 7 B12, etc.) systems by checking the model and serial numbers on the PC components.

For Allura Xper systems, locate the Imaging Processing PC, Host PC, or FlexVision PC; for Azurion systems, locate the XRay PC, Suite PC, or FlexViewing PC to verify identifying information.

Verify your serial number against the extensive list provided in the recall notice, specifically checking for UDI-DI codes such as 00884838059030 (Allura) or 00884838085275 (Azurion).

Immediately contact your Philips service representative or Philips Medical Systems Nederland B.V. to schedule an inspection and potential repair of the computer's Disk Bay.

If the system fails during a procedure, follow your facility's emergency protocols for equipment failure to ensure patient safety.

For further information or technical guidance, contact Philips Medical Systems at their Netherlands headquarters or your local authorized distributor.

Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding this safety recall.

Affected Products

Product: Philips Allura Xper Interventional Fluoroscopic X-ray Systems

Model / REF:

722003

722010

722026

722022

722005

722011

722027

722001

722006

722012

722028

722008

722013

722025

722023

722035

722029

722058

722059

722038

722039

Lot Numbers:

UDI-DI 00884838059030

UDI-DI 00884838059191

UDI-DI 00884838054189

UDI-DI 00884838080805

UDI-DI 00884838054196

UDI-DI 00884838059115

UDI-DI 00884838059054

UDI-DI 00884838059207

UDI-DI 00884838054202

UDI-DI 00884838059269

UDI-DI 00884838059061

UDI-DI 00884838059085

UDI-DI 00884838054240

UDI-DI 00884838054219

UDI-DI 00884838059122

UDI-DI 00884838054226

Product: Philips Azurion Interventional Fluoroscopic X-ray Systems

Model / REF:

722063

722221

722064

722222

722228

722067

722225

722068

722226

722078

722223

722079

722224

Lot Numbers:

UDI-DI 00884838085275

UDI-DI 00884838086777

UDI-DI 00884838099203

UDI-DI 00884838085282

UDI-DI 00884838099210

UDI-DI 00884838099234

UDI-DI 00884838059290

UDI-DI 00884838064775

UDI-DI 00884838085350

UDI-DI 00884838099265

UDI-DI 00884838059207

UDI-DI 00884838085367

UDI-DI 00884838101883

UDI-DI 00884838099272

UDI-DI 00884838085251

UDI-DI 00884838101890

UDI-DI 00884838099241

UDI-DI 00884838059221

UDI-DI 00884838085268

UDI-DI 00884838059184

UDI-DI 00884838099258

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93781

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Philips Medical Systems Nederland B.V.; Authorized Medical Device Distributors

Manufactured In: Netherlands

Units Affected: 2 products (13, 133 (3,408 US; 9,725 ROW))