Quick Facts at a Glance
- Recall Date
- March 3, 2026
- Hazard Level
- HIGH
- Brands
- Philips, Philips
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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, Philips
- Product type
- Interventional X-ray System
- Model numbers
- (1) System Code: 722078, (2) System Code: 722223, (3) System Code: 722233, UDI: 00884838085251, System Serial Number: 302, 585, 410, 753 +14 more
- Sold at
- Unknown
- 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 M12 is an interventional X-ray imaging system used in catheter-based procedures. Hospitals deploy it for guidance during complex interventions.
Why This Is Dangerous
A fault in the wired foot switch can prevent X-ray imaging from starting or cause intermittent imaging, potentially compromising patient safety during procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals must halt use of affected units to prevent diagnostic delays or errors that could impact patient outcomes and procedure planning.
Practical Guidance
How to identify if yours is affected
- Check system code labels on the unit: 722078, 722223, 722233.
- Verify the UDI: 00884838085251.
- Confirm System Serial Number: 302.
Where to find product info
Device labeling near the control panel and the recall notification letter.
What timeline to expect
Remedy actions may take 4-8 weeks for replacement or service coordination.
If the manufacturer is unresponsive
- Escalate to the hospital risk management office.
- File a notice with the FDA if the provider or manufacturer delays remediation.
- Keep records of all communications and actions taken.
How to prevent similar issues
- Verify recall status before deploying any imaging system.
- Maintain updated contact with the manufacturer for service advisories.
- Ensure your biomedical engineering team tracks device recalls.
- Document serials and UDI in inventory records.
Documentation advice
Keep the recall letter, device labels, serial numbers, and all correspondence as part of your compliance and risk records.
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Product Details
Model codes: (1) 722078, (2) 722223, (3) 722233. UDI: 00884838085251. System Serial Number: 302. Additional identifiers include: 585, 410, 753, 523, 293, 840, 291, 536, 537, 870, 613, 598, 679, 224, 829, 249, 546. Sold/distributed: Domestic nationwide and international distribution to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala,H
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,994 units recalled (360 US, 1,634 OUS)
- System Serial Number 302
- Domestic: Nationwide distribution; International: listed in the recall notice
- Recall Date: 2026-03-03; Report Date: 2026-04-08
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Safety Guide
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