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) 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.
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 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
- Check if your model number is 722064, 722222, 722230, or 722280.
- Verify the software version is R1.X, R2.X, or R3.X.
- 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
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