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, 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
- (1) System Code: 722227, (2) 722231, UDI: 00884838099227, System Serial Number: 265, 135, 88, 276, 264 +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
Azurion is Philips’ family of interventional imaging systems used in radiology suites for real-time X-ray guided procedures. The Azurion 5 M12 is one model within that family. Healthcare facilities deploy these systems to perform diagnostic and therapeutic procedures.
Why This Is Dangerous
The defect may prevent X-ray imaging from starting or cause intermittent imaging when using the wired foot switch, potentially delaying diagnosis and treatment.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt use of the affected devices and reallocate imaging work. The recall could impact patient throughput and procedure scheduling while replacements or service arrangements are arranged.
Practical Guidance
How to identify if yours is affected
- Verify system code 722227 or 722231 on the device label.
- Review system serial numbers against the list in the recall documentation.
Where to find product info
Look for the recall notification letter and the FDA recall page linked in the notice.
What timeline to expect
Remediation timelines vary by hospital and supplier; expect several weeks for replacement or service arrangements.
If the manufacturer is unresponsive
- Escalate to hospital safety officer
- Contact Philips support and your regulatory liaison
- File a recall complaint with the appropriate health authority if needed
How to prevent similar issues
- Verify device integrity before procedures in non-urgent cases
- Maintain up-to-date service agreements with the manufacturer
- Document all communications and device status
Documentation advice
Keep the recall letter, serial numbers, system codes, and all correspondence. Photograph the device label and store communications for records
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Product Details
Model numbers and identifiers include System Code 722227 and 722231. UDI is 00884838099227. System Serial Numbers include 265 and 135, 88, 276, 264, 271, 63, 238, 360, 23, 127, 159, 197, 149, 54, 56, 230, 192. Domestic and international distribution is listed below.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 345 total units recalled
- Domestic: 10 units; International: 335 units
- System Codes: 722227 and 722231
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Safety Guide
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