Quick Facts at a Glance
- Recall Date
- October 27, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 North America
- Product type
- Interventional Fluoroscopic X-ray System
- Model numbers
- Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 27, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: N/A
About This Product
The Azurion 7 M20 is a medical imaging device used in interventional procedures to provide real-time X-ray imaging. Healthcare providers rely on this equipment for precise diagnostics and treatment planning.
Why This Is Dangerous
The device's missing SSD spacer compromises the required radiation safety standards, potentially leading to harmful radiation exposure during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate action from healthcare providers to mitigate risks associated with potential radiation exposure, affecting operational workflow.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device, which is 722234.
- Confirm that the device is a Philips Azurion 7 M20.
- Check the shipping dates between July 2024 and June 2025.
Where to find product info
The model number can typically be found on the device's identification label or user manual.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Contact Philips customer service directly for escalation.
- Document all communications and follow up regularly.
How to prevent similar issues
- Ensure any medical device purchased meets all safety standards before use.
- Check for any recalls on medical devices regularly.
- Consult healthcare providers about the latest safety guidelines.
Documentation advice
Keep records of your device purchase, including photos, receipts, and correspondence with Philips regarding the recall.
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Product Details
The recalled product is the Azurion R3.0, Model Number 722234, commercially known as Azurion 7 M20. It was distributed in the U.S. from July 2024 to June 2025.
Key Facts
- Recall date: October 27, 2025
- Quantity recalled: 110 units
- FDA minimum source-skin distance requirement: 38 cm
- Health risk: High due to potential radiation exposure
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Safety Guide
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