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 Equipment
- Model numbers
- System Model Numbers: (1)722227, (2)722231, UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740, 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 M12 is a medical imaging system used in healthcare settings for diagnostic purposes. Healthcare providers rely on its functionality for patient procedures and assessments.
Why This Is Dangerous
The hazard arises from the potential for the table to move unexpectedly, which can endanger patients during procedures. The malfunction can occur even when safety features, such as table locks, are activated.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall significantly impacts healthcare providers who use the device, as it requires immediate cessation of use, potentially delaying patient care.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Check the software version against the recalled versions.
- Contact Philips for confirmation of recall status.
Where to find product info
Model numbers and software versions are typically found on the device's label or in the user manual.
What timeline to expect
Expect a timeline of 4-6 weeks for processing any refunds or replacements once initiated.
If the manufacturer is unresponsive
- Document your attempts to contact Philips.
- Reach out to regulatory bodies if necessary.
How to prevent similar issues
- Always verify that medical devices have the latest software updates.
- Check for recalls periodically before use.
- Ensure safety features function correctly before each use.
Documentation advice
Keep all related documents, including purchase receipts and correspondence with Philips as evidence.
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Product Details
The recall affects Azurion 5 M12 System Model Numbers 722227 and 722231. All versions of software R1.X, R2.X, and R3.X are included. The product has been distributed worldwide, with 10 units in the U.S. and 316 units internationally.
Key Facts
- 10 units in the US
- 316 units distributed internationally
- Hazard involves unexpected table movement
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Safety Guide
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