What models are affected by the Philips Azurion 7 M20 recall?

The recall covers Azurion 7 M20 systems with System Codes 722079, 722224, 722234 and 722282 (OUS only). It also lists the UDI 00884838085268 and associated system serials.

What is the defect in the Azurion 7 M20 system?

The wired foot switch may fail to initiate X-ray imaging or produce intermittent imaging, potentially interrupting procedures.

Who is affected by this recall?

Hospitals, clinics and other healthcare facilities that purchased the Azurion 7 M20 system worldwide are affected.

What should facilities do now?

Stop using the device immediately. Follow Philips’ recall instructions and contact Philips Medical Systems Nederland B.V. or a healthcare provider for guidance.

Will I receive a refund or replacement?

Philips lists recall instructions and may offer remediations consistent with clinical safety. Contact Philips for specifics on refunds, repairs or replacements.

How can I verify if my device is affected?

Check the System Code on the device label (722079, 722224, 722234, 722282), match the UDI 00884838085268 and verify the system serial number if provided.

Where can I get recall updates?

Refer to the FDA enforcement page linked to the recall and Philips’ official recall notices. Updates are posted by Philips and the regulatory agencies.

What is the risk to patients?

If imaging fails to start or is intermittent during a procedure, there can be delays or interruptions in diagnostic or therapeutic steps. The recall is designated high risk.

How long does the recall remediation take?

Remediation timelines vary by facility and replacement or repair options. Philips indicates follow-up instructions and may require device return or update processes.

Should I continue using alternative imaging systems?

Facilities should transition to safe alternatives as advised by Philips and their clinical leadership, ensuring patient care is not compromised.

HIGHMarch 3, 2026

Philips Azurion 7 M20 X-ray System Recall Affects 5,167 Units Worldwide (2026)

Philips Medical Systems Nederland recalled 5,167 Azurion 7 M20 X-ray imaging systems sold to healthcare facilities in the U.S. and internationally. The wired foot switch can fail to initiate imaging or produce intermittent imaging. Hospitals and clinics should stop using the device and follow recall instructions from Philips, with notification by letter to affected parties.

Quick Facts at a Glance

Recall Date: March 3, 2026
Hazard Level: HIGH
Brand: Philips Medical Systems Nederland
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter

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About This Product

Azurion 7 M20 is Philips' interventional radiology X-ray imaging system used in hospitals and clinics to guide procedures.

Why This Is Dangerous

A wired foot switch fault can prevent imaging from starting or cause intermittent imaging, potentially affecting procedure workflow and patient safety.

Industry Context

This recall is not presented as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals may face workflow disruptions and the need to halt ongoing procedures until devices are replaced or repaired.

Practical Guidance

How to identify if yours is affected

Check System Code on the device label: 722079, 722224, 722234, 722282.
Verify UDI: 00884838085268.
Note System Serial Number if present (e.g., 1023).
Confirm model/serial details with your facilities’ asset records.

Where to find product info

System Code label near the power input; UDI label on the device; service plate may list the System Serial Number.

What timeline to expect

Plan 4-8 weeks for remediation, depending on availability of replacements or repairs.

If the manufacturer is unresponsive

Escalate to hospital risk management.
Contact Philips recall support via official channels.
File a formal record and seek regulatory guidance if needed.

How to prevent similar issues

Verify recall status before activating any interventional imaging system.
Request updated firmware or hardware remediation from the manufacturer.
Document all communications and store recall documentation with asset records.

Documentation advice

Keep the recall notification, device labels, asset tags, photos of labels, and all correspondence with Philips or hospital administration.

Product Details

System Code: 722079; 722224; 722234; 722282 (OUS only). UDI: 00884838085268. System Serial Numbers: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534. Quantity: 5167 units (1728 US, 3439 OUS). Distribution: Domestic nationwide and international in multiple countries.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

5,167 units affected worldwide (1728 US, 3439 OUS).
Wired foot switch can fail to initiate X-ray imaging or cause intermittent imaging.
Recall date: 2026-03-03; notification date: 2026-04-08.
Device is distributed to hospitals and clinics nationwide and in numerous countries.

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

6/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Imaging Equipment

Product TypeX-ray imaging system

Product Details

Sep 3, 2025

Philips Medical Systems Nederland

The BIOS