Quick Facts at a Glance
- Recall Date
- December 8, 2025
- 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
- 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
- Medical Imaging Systems
- Model numbers
- Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 8, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
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: E-Mail
About This Product
Philips Azurion Systems are advanced medical imaging devices used in healthcare settings for diagnostic procedures. They provide real-time imaging capabilities crucial for effective patient care.
Why This Is Dangerous
The identified software issues can lead to critical failures in the imaging process, potentially jeopardizing patient safety during medical examinations.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate action from healthcare providers to avoid using malfunctioning equipment, which could disrupt patient care and diagnostic accuracy.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your device
- Check if the model number matches the recalled list
- Review the recall notice for specific software version details
Where to find product info
The model number and software version can typically be found on the device's front panel or user manual.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks after contacting Philips.
If the manufacturer is unresponsive
- Document all communication attempts with Philips
- Reach out to your healthcare provider for assistance
- File a report with the FDA if necessary
How to prevent similar issues
- Regularly update software on medical devices
- Stay informed about recalls in the medical device industry
Documentation advice
Keep records of all correspondence regarding the recall, including emails and receipts for any related purchases.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves Philips Azurion Systems R3.0, including models 722229, 722230, 722231, 722232, 722235, 722236, 722233, and 722234. The systems were distributed worldwide, including the US and various countries. These models were sold globally.
Key Facts
- Recalled models include Azurion 3 M12, M15, Azurion 5 M12, M20, and Azurion 7 models
- Nine software issues identified
- Stop using devices immediately
- Contact Philips for instructions
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.