Quick Facts at a Glance
- Recall Date
- December 12, 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 Versions: R2.1.10 and R2.2.10. 1. Model Number (UDI): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)96, (01)00884838085275(21)98 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 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
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional 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: Letter
About This Product
Philips Azurion Systems are advanced medical imaging devices used in healthcare settings for various diagnostic and therapeutic procedures. They are designed to enhance imaging quality and support patient care.
Why This Is Dangerous
The identified software issues can lead to critical system failures which may disrupt medical procedures and affect patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may disrupt healthcare services where these devices are employed, posing risks to patient safety and care continuity.
Practical Guidance
How to identify if yours is affected
- Locate the model number and software version on your Philips Azurion System.
- Compare your model and software version with the recall details provided by Philips.
- Check for notifications from Philips regarding the recall.
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 potential delays in processing refunds or replacements as Philips addresses the recall.
If the manufacturer is unresponsive
- Document all communications with Philips regarding your recall inquiries.
- Follow up with your healthcare provider for assistance if Philips does not respond.
- Consider filing a complaint with relevant health authorities if necessary.
How to prevent similar issues
- When purchasing medical devices, verify their safety records and any recent recalls.
- Stay informed about product updates and software versions from manufacturers.
- Consult with healthcare professionals on device reliability and safety.
Documentation advice
Keep records of all communications regarding the recall, including dates, responses, and any relevant documentation.
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Product Details
The recall includes Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Specific models affected are Azurion 3 M12, M15; Azurion 5 M12, M20; and Azurion 7 B12, B20, M12, M20.
Key Facts
- Software versions R2.1.10 and R2.2.10 affected
- Worldwide distribution including the U.S.
- Six hazardous software issues identified
- No injuries or deaths reported
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Safety Guide
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