Quick Facts at a Glance
- Recall Date
- December 12, 2025
- Hazard Level
- HIGH
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- X-ray Imaging System
- Model numbers
- Software Version Number: R3.1, (1) Model Number: 722221, System Product Name: Azurion 3 M12, UDI-DI: 00884838099203, Serial Numbers: (2) Model Number: 722222, System Product Name: Azurion 3 M15, UDI-DI: 00884838099210, Serial Numbers: (3) Model Number: 722223 +12 more
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
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
About This Product
The Philips Azurion system is used in medical environments for X-ray imaging and interventional procedures. It provides advanced imaging capabilities essential for healthcare providers.
Why This Is Dangerous
The identified software issues can lead to critical failures in imaging and motorized functions, impacting patient care and safety during procedures. Continuous restart mode and longitudinal position errors may obstruct timely medical interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who rely on the Azurion system for accurate imaging. The urgency is high, and immediate action is required to avoid potential risks.
Practical Guidance
How to identify if yours is affected
- Check the model number of your Philips Azurion system against the recalled models.
- Verify the software version to see if it is R3.1.
- Look for the serial number on the device to confirm if it is affected.
Where to find product info
Model numbers and serial numbers can typically be found on the back or bottom of the device, or in the user manual.
What timeline to expect
Expect 4-6 weeks for processing of refunds or replacements once initiated with Philips.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Reach out to a healthcare regulatory body for further assistance if Philips does not respond.
How to prevent similar issues
- Inquire about software updates and safety certifications before purchasing medical devices.
- Regularly check for recalls and safety notices from manufacturers.
- Ensure proper training for staff on the use of medical devices.
Documentation advice
Keep records of your device’s model and serial numbers, any communications with Philips, and copies of the recall notice.
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Product Details
The recall involves Philips Azurion systems with software version R3.1. Affected model numbers include 722221, 722222, 722223, 722224, 722225, 722226, and 722227. The devices were distributed internationally.
Key Facts
- Software Version: R3.1
- Issues with imaging functionality
- Potential for incorrect image content
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Safety Guide
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