Quick Facts at a Glance
- Recall Date
- March 3, 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, PREGNANT
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
- X-ray Imaging System
- Model numbers
- 722063, 722221, 722229, UDI 00884838085275
- 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
Azurion 3 M12 is a interventional X-ray imaging system used in hospitals for guidance during procedures.
Why This Is Dangerous
A failure or intermittent operation of the imaging function can affect diagnostic or procedural outcomes.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals may experience procedure delays or imaging downtime until devices are serviced or replaced.
Practical Guidance
How to identify if yours is affected
- Identify device by system code 722063, 722221, or 722229
- Record UDI 00884838085275 and System Serial Number 122
- Document all identifiers and the recall notice
- Do not power up or use affected units
Where to find product info
Check device label and the recall notice for system codes, UDI, and serial numbers
What timeline to expect
Philips will provide remediation instructions; timelines vary by region
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Maintain communication with Philips recall team
- If needed, consult regulatory authorities for guidance
How to prevent similar issues
- Maintain up-to-date recall notifications for imaging systems
- Implement asset-tracking of critical medical devices by system code and serial number
- Verify recall status before using any interventional X-ray system in procedures
Documentation advice
Keep recall letter, device identifiers, service reports, and all correspondence with Philips for records
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
System Codes: (1)722063, (2)722221, (3)722229. UDI: 00884838085275. System Serial Number: 122. Additional identifiers include: 56, 64, 131, 84, 132, 96, 98, 108, 77, 82, 145, 47, 146, 80, 102, 43, 117. Quantity: 298 units (27 US, 271 OUS). Distribution: Domestic nationwide; International in numerous countries. Sold through healthcare facilities worldwide. Recall date: 2026-03-03. Status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 298 units recalled (27 US, 271 OUS)
- System Serial Number: 122
- Domestic distribution nationwide; extensive international distribution across many countries
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.