Quick Facts at a Glance
- Recall Date
- March 3, 2026
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems Nederland
- 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
- Product type
- Azurion 3 M15 Interventional X-ray Imaging System
- Model numbers
- (1) System Code: 722064, (2) 722222, (3) 722230, (4) 722280, UDI: 00884838085282, System Serial Number: 209, 238, 201 +15 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 3, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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
The Azurion 3 M15 is an interventional X-ray imaging system used in catheterization labs for cardiovascular procedures. It supports image-guided interventions and requires reliable foot-switch operation during workflows.
Why This Is Dangerous
A faulty wired foot switch can fail to start X-ray imaging or produce intermittent imaging, potentially affecting procedure performance and patient assessment.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Clinicians may experience imaging delays or interruptions during procedures, which could affect diagnostic accuracy and treatment decisions.
Practical Guidance
How to identify if yours is affected
- Verify system code is 722064, 722222, 722230, or 722280 (OUS only).
Where to find product info
Recall letter from Philips and the FDA recall page linked in Philips communications.
What timeline to expect
Recall remediation timelines typically run 4-8 weeks for refunds or replacements where applicable; for medical devices, service arrangements are made,
If the manufacturer is unresponsive
- Escalate to hospital administration or the device coordinator.
- Document all attempts to contact Philips and the healthcare provider.
- Consider filing complaints with the manufacturer and regulatory bodies if no response is received within stated timelines.
How to prevent similar issues
- In the future, verify device recalls for interventional imaging systems before use.
- Check for standard recall notices and ensure service contracts include recall coordination.
- Confirm replacement or service options through the manufacturer before use of any device in critical procedures.
Documentation advice
Keep a copy of the recall letter, record serial numbers and system codes, save all correspondence with Philips and healthcare providers, and document all service actions.
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Product Details
Model numbers and identifiers: System Code 722064, 722222, 722230, 722280 (OUS Only). UDI: 00884838085282. System Serial Numbers include 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169. Total units recalled: 798 (US: 42; OUS: 756). Distribution: Domestic nationwide in the US and international to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, CostaR
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Total units recalled: 798
- US units recalled: 42
- Hazard: X-ray imaging may not initiate or may be intermittent with wired foot switch
- No injuries reported
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Safety Guide
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