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
- Interventional X-ray imaging system
- Model numbers
- 722067, 722225, 722235, 221, 42, 172, 173, 109 +13 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 7 B12 is an interventional X-ray imaging system used in hospital procedure rooms to guide minimally invasive interventions.
Why This Is Dangerous
A defect in the wired foot switch can prevent X-ray imaging from starting or cause intermittent operation, compromising procedural imaging.
Industry Context
This recall is not noted as part of a broader industry pattern.
Real-World Impact
Hospitals may experience imaging delays during procedures. The recall covers 670 units across many countries and requires immediate action to prevent workflow disruption and potential patient safety risk.
Practical Guidance
How to identify if yours is affected
- Identify System Code: 722067, 722225, 722235
Where to find product info
On device data plate, user manual, or installation documentation for System Code, UDI, and Serial Numbers.
What timeline to expect
Remediation timelines vary by region; Philips will issue instructions and facilitate service or replacement as needed.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact Philips recall line or regional representative
- If necessary, file a complaint with health authorities or the FDA
- Document all communications and timelines
How to prevent similar issues
- Verify system codes and UDIs during audits
- Schedule service updates as recommended by Philips
- Maintain up-to-date contact with the Philips service team and regional reps
- Document all recalls and ensure unit culling from clinical use if advised
Documentation advice
Keep the recall notification, record all serial numbers and statuses, preserve any replacement or service tickets, and photograph data plates for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Azurion 7 B12 Interventional X-ray Imaging System System Codes: 722067, 722225, 722235 UDI: 00884838085350 System Serial Numbers: 221, 42, 172, 173, 109, 250, 103, 192, 92, 114, 225, 69, 214, 41, 98, 81, 123, 278 Quantity recalled: 670 total (106 US, 564 OUS) Domestic distribution: Nationwide International distribution: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Côte d’Ivoire, Croatia,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 670 total units recalled (106 US, 564 OUS)
- Hazard: X-ray imaging may not start or may be intermittent when using the wired foot switch
- Remedy: Stop using immediately; follow manufacturer instructions; contact Philips or healthcare team
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
