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
- 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 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.
Recall announced
January 26, 2026
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
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
- Check the model number on the device to see if it matches 722063, 722221, or 722229.
- Verify the software version is R1.X, R2.X, or R3.X.
- 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)
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Safety Guide
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