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
- Azurion 5 M20 System
- Model numbers
- System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only), UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A, 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 5 M20 system is a medical imaging device used in healthcare settings for procedures requiring advanced imaging capabilities. Healthcare providers purchase this device for its advanced features and reliability in patient care.
Why This Is Dangerous
The defect causes the imaging table to move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This can lead to potential injury during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses an immediate safety concern for healthcare providers and patients, requiring urgent action to prevent potential injuries.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device for 722228, 722232, or 722281.
- Verify if your software version is R1.X, R2.X, or R3.X.
- Consult with your healthcare provider for confirmation.
Where to find product info
Model numbers and software versions can typically be found on the device's identification plate or user manual.
What timeline to expect
Expect a refund processing timeline of 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Document all communications with Philips Medical Systems.
- Consider reaching out to the FDA or local health authorities for guidance.
How to prevent similar issues
- Look for devices with updated safety features and certifications.
- Research recalls before purchasing medical devices.
- Consult with healthcare professionals regarding the safety of medical devices.
Documentation advice
Keep records of your purchase, communications with the manufacturer, and any incidents related to the use of the device.
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Product Details
The recalled Azurion 5 M20 systems include model numbers 722228, 722232, and 722281 (OUS only). Devices are affected across all software versions: R1.X, R2.X, R3.X. They were distributed worldwide, including the U.S. and numerous international markets.
Key Facts
- Recall date: January 26, 2026
- Total units recalled: 922
- No reported injuries or incidents
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Safety Guide
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