PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Systems Recalled for Potential X-ray Loss and Procedure Stops

Agency Publication Date: September 30, 2024

Summary

Philips Medical Systems is recalling approximately 1,063 Azurion Systems in the United States (and 2,136 internationally) because the X-ray functionality may suddenly stop working when the system's disk capacity is full. This defect causes an immediate interruption of medical procedures while the patient is on the table, which could lead to complications or delays in critical care. The affected units include multiple Azurion models using software versions R2.2.O, R2.2.1, R2.2.3, R2.2.5, and R2.2.6.

Risk

If the system's storage disk reaches full capacity during a procedure, the X-ray imaging will cease to function without warning. This sudden loss of visualization can result in procedural delays or the need for emergency patient transfer, increasing the risk of patient harm during invasive medical interventions.

What You Should Do

Identify if your facility uses a Philips Azurion System (Models 3M12, 3M15, SM12, SM20, 7B12/12, 7820/15, 7M12, or 7M20) by checking the model number on the system's identification plate.
Verify your system software version; this recall specifically affects software versions R2.2.O, R2.2.1, R2.2.3, R2.2.5, and R2.2.6.
Check for specific device identifiers, including model numbers 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, and 722224.
Contact your healthcare facility's biomedical engineering department or the manufacturer, Philips Medical Systems, to schedule a software update or disk maintenance to prevent storage-related shutdowns.
Immediately contact Philips Medical Systems Nederland B.V. for further instructions and technical support regarding this safety notification.
For additional questions, contact the FDA medical device hotline at 1-888-463-6332.

Your Remedy Options

Other Action

Manufacturer technical intervention and guidance

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

Affected Products

Product: Philips Azurion 3M12

Model / REF:

722063

722221

UPC Codes:

00884838085275

00884838099203

Product: Philips Azurion 3M15

Model / REF:

722064

722222

UPC Codes:

00884838085282

00884838099210

Product: Philips Azurion SM12

Model / REF:

722227

UPC Codes:

00884838099227

Product: Philips Azurion SM20

Model / REF:

722228

UPC Codes:

00884838099234

Product: Philips Azurion 7B12/12

Model / REF:

722067

722225

UPC Codes:

00884838085350

00884838099265

Product: Philips Azurion 7820/15

Model / REF:

722068

722226

UPC Codes:

00884838085367

00884838099272

Product: Philips Azurion 7M12

Model / REF:

722078

722223

UPC Codes:

00884838085251

00884838099241

Product: Philips Azurion 7M20

Model / REF:

722079

722224

UPC Codes:

00884838085268

00884838099258

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92165

Status: Active

Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold By: Philips Medical Systems; Direct medical device distributors

Manufactured In: Netherlands

Units Affected: USA: 1063 R.O.W. 2136

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

Risk

What You Should Do

Identify if your facility uses a Philips Azurion System (Models 3M12, 3M15, SM12, SM20, 7B12/12, 7820/15, 7M12, or 7M20) by checking the model number on the system's identification plate.

Verify your system software version; this recall specifically affects software versions R2.2.O, R2.2.1, R2.2.3, R2.2.5, and R2.2.6.

Check for specific device identifiers, including model numbers 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, and 722224.

Contact your healthcare facility's biomedical engineering department or the manufacturer, Philips Medical Systems, to schedule a software update or disk maintenance to prevent storage-related shutdowns.

Immediately contact Philips Medical Systems Nederland B.V. for further instructions and technical support regarding this safety notification.

For additional questions, contact the FDA medical device hotline at 1-888-463-6332.

Affected Products

Product: Philips Azurion 3M12

Model / REF:

722063

722221

UPC Codes:

00884838085275

00884838099203

Product: Philips Azurion 3M15

Model / REF:

722064

722222

UPC Codes:

00884838085282

00884838099210

Product: Philips Azurion SM12

Model / REF:

722227

UPC Codes:

00884838099227

Product: Philips Azurion SM20

Model / REF:

722228

UPC Codes:

00884838099234

Product: Philips Azurion 7B12/12

Model / REF:

722067

722225

UPC Codes:

00884838085350

00884838099265

Product: Philips Azurion 7820/15

Model / REF:

722068

722226

UPC Codes:

00884838085367

00884838099272

Product: Philips Azurion 7M12

Model / REF:

722078

722223

UPC Codes:

00884838085251

00884838099241

Product: Philips Azurion 7M20

Model / REF:

722079

722224

UPC Codes:

00884838085268

00884838099258