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Philips Medical Systems Recalls Azurion 3 M12 Due to Hazard

Philips Medical Systems recalled 291 Azurion 3 M12 systems on January 26, 2026, due to a risk of unexpected table movement. This may occur when the Reset Geometry button is pressed, even if a table lock is active. The recall affects 27 units in the U.S. and 264 units internationally.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesSystem Model Numbers: (1) 722063(2) 722221(3) 722229

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) 722063, (2) 722221, (3) 722229, UDI-DIs: (1) 884838085275, (2) 884838099203, (3) 884838116726, Serial Numbers: All
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 M12 system is a medical imaging device used in healthcare settings for various procedures. Healthcare providers purchase this system for its advanced imaging capabilities.

Why This Is Dangerous

The hazard arises from the potential for the table to move unexpectedly, which can lead to accidents during medical procedures. This can occur even with a table lock activated, creating a risk for patients and staff.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may disrupt healthcare services and pose safety risks during imaging procedures, necessitating immediate action from affected facilities.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device to see if it matches 722063, 722221, or 722229.
  2. Verify the software version is R1.X, R2.X, or R3.X.
  3. Contact Philips Medical Systems if you are unsure about the model or software version.

Where to find product info

The model number and software version can usually be found on the identification label of the device or within the device's software menu.

What timeline to expect

Expect a processing timeline of 4-6 weeks for refunds or replacements.

If the manufacturer is unresponsive

  • Document all interactions with Philips regarding the recall.
  • Reach out again through alternative contact methods if you receive no response.
  • Consider filing a complaint with the appropriate regulatory body if issues persist.

How to prevent similar issues

  • When purchasing medical devices, look for safety certifications and recent recalls.
  • Stay informed about product changes or updates from manufacturers.

Documentation advice

Keep all receipts, correspondence related to the recall, and any photos of the product for your records.

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Product Details

The recalled Azurion 3 M12 systems include model numbers 722063, 722221, and 722229. All software versions R1.X, R2.X, and R3.X are affected. The systems were distributed worldwide.

Key Facts

  • Recall Date: January 26, 2026
  • Report Date: February 18, 2026
  • Quantity Affected: 291 units (27 US, 264 OUS)

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) 722063
(2) 722221
(3) 722229
UDI-DIs: (1) 884838085275
(2) 884838099203
+2 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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