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
- 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 Medical Systems Nederland B.V.
- Product type
- Azurion 5 M20 Interventional Imaging System
- Model numbers
- Azurion 5 M20, System Code 722228, System Code 722232, System Code 722281
- 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 5 M20 is Philips’ interventional X-ray imaging system used in cath labs and hybrid operating rooms to guide procedures.
Why This Is Dangerous
A wired foot switch can fail to initiate X-ray imaging or produce intermittent imaging, compromising real-time guidance during procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals may need to halt procedures requiring X-ray guidance using this system. No injuries have been reported yet, but patient safety could be at risk during imaging-critical steps.
Practical Guidance
How to identify if yours is affected
- Verify System Code: 722228, 722232, or 722281 (OUS).
- Check UDI: 00884838099234 on the device label.
- Consult the recall letter for model specifics and instructions.
Where to find product info
Recall notices and official guidance are available from Philips and the FDA recall page.
What timeline to expect
Recall instructions will be issued by Philips; no specific refund or replacement timeline is provided.
If the manufacturer is unresponsive
- Escalate to hospital risk management and document all communications.
- Contact FDA complaints or manufacturer for escalation if no response within a reasonable timeframe.
How to prevent similar issues
- Keep devices updated on recall notices.
- Verify labels and system codes during procurement.
- Coordinate with suppliers to confirm any required upgrades or service actions.
Documentation advice
Maintain a copy of the recall notice, record system codes, UDI, and all correspondence with Philips.
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Product Details
Quick reference: - Product: Azurion 5 M20 Interventional Imaging System - System Codes: 722228, 722232, 722281 (OUS) - UDI: 00884838099234 - Quantity: 920 units total (168 US, 752 OUS) - Countries: Domestic US distribution and international distribution across numerous countries - Manufacturer: Philips Medical Systems Nederland B.V. (Netherlands)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Total units recalled: 920
- Hazard: X-ray imaging may not initiate or may be intermittent when using wired foot switch
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Safety Guide
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