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
- X-ray imaging system
- Model numbers
- System Code 722079, System Code 722224, System Code 722234, System Code 722282, UDI 00884838085268, System Serial Number 1023, 645, 646 +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
Azurion 7 M20 is Philips' interventional radiology X-ray imaging system used in hospitals and clinics to guide procedures.
Why This Is Dangerous
A wired foot switch fault can prevent imaging from starting or cause intermittent imaging, potentially affecting procedure workflow and patient safety.
Industry Context
This recall is not presented as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may face workflow disruptions and the need to halt ongoing procedures until devices are replaced or repaired.
Practical Guidance
How to identify if yours is affected
- Check System Code on the device label: 722079, 722224, 722234, 722282.
- Note System Serial Number if present (e.g., 1023).
- Confirm model/serial details with your facilities’ asset records.
Where to find product info
System Code label near the power input; UDI label on the device; service plate may list the System Serial Number.
What timeline to expect
Plan 4-8 weeks for remediation, depending on availability of replacements or repairs.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Contact Philips recall support via official channels.
- File a formal record and seek regulatory guidance if needed.
How to prevent similar issues
- Verify recall status before activating any interventional imaging system.
- Request updated firmware or hardware remediation from the manufacturer.
- Document all communications and store recall documentation with asset records.
Documentation advice
Keep the recall notification, device labels, asset tags, photos of labels, and all correspondence with Philips or hospital administration.
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Product Details
System Code: 722079; 722224; 722234; 722282 (OUS only). UDI: 00884838085268. System Serial Numbers: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534. Quantity: 5167 units (1728 US, 3439 OUS). Distribution: Domestic nationwide and international in multiple countries.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 5,167 units affected worldwide (1728 US, 3439 OUS).
- Wired foot switch can fail to initiate X-ray imaging or cause intermittent imaging.
- Recall date: 2026-03-03; notification date: 2026-04-08.
- Device is distributed to hospitals and clinics nationwide and in numerous countries.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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