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Philips Medical Systems Recalls Azurion 3 M15 System Due to Hazard

Philips Medical Systems Nederland B.V. recalled 802 Azurion 3 M15 systems on January 26, 2026. The systems may move unexpectedly, posing a risk to patients and healthcare providers. Consumers should stop using the device immediately and follow recall instructions.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesSystem Model Numbers: (1) 722064(2) 722222(3) 722230

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 26, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 26, 2026
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product type
Medical Imaging System
Model numbers
System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only), UDI-DIs: (1) 884838085282, (2) 884838099210, (3) 884838116733, (4)N/A +1 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 26, 2026

  2. Reported by FDA DEVICE

    February 18, 2026

  3. RecallRadar source check

    February 25, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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: N/A

About This Product

The Azurion 3 M15 system is used in medical imaging procedures to assist healthcare providers in diagnosing and treating patients. It is designed to provide advanced imaging capabilities in a clinical setting.

Why This Is Dangerous

The hazard arises when the Reset Geometry button is pressed under certain conditions, causing the table to move unexpectedly. This defect could endanger patient safety during medical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must cease using the device immediately, which could disrupt scheduled medical procedures and require alternative solutions.

Practical Guidance

How to identify if yours is affected

  1. Check if your model number is 722064, 722222, 722230, or 722280.
  2. Verify the software version is R1.X, R2.X, or R3.X.
  3. Consult with your healthcare provider to confirm if your system is affected.

Where to find product info

Model and serial numbers can typically be found on the device's labeling or in the user manual.

What timeline to expect

Expect a response for refund or replacement processing within 4-6 weeks after contacting Philips.

If the manufacturer is unresponsive

  • Document all communications with Philips.
  • Follow up with Philips if no response is received within a reasonable timeframe.
  • Consider filing a complaint with regulatory agencies if issues persist.

How to prevent similar issues

  • Look for devices with updated safety features and certifications.
  • Always check for recalls before purchasing medical equipment.
  • Consult with healthcare experts regarding the latest medical devices and their safety records.

Documentation advice

Keep records of all communications, receipts, and documentation related to the recall for future reference.

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Product Details

The recalled models include Azurion 3 M15 System Model Numbers: 722064, 722222, 722230, and 722280 (OUS only). Affected software versions include R1.X, R2.X, R3.X. The systems were distributed worldwide, with 45 units in the U.S. and 757 units in other countries.

Key Facts

  • Movement hazard when using Reset Geometry
  • No reported injuries
  • Immediate cessation of use advised

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
System Model Numbers: (1) 722064
(2) 722222
(3) 722230
(4)722280(OUS only)
UDI-DIs: (1) 884838085282
+4 more
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
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Philips Medical Systems recalled 326 Azurion 5 M12 systems on January 26, 2026. The table may move unexpectedly when the Reset Geometry button is pressed, posing a risk to patients and healthcare providers. Immediate cessation of use is advised.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Under certain
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