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
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
- System Code: 722005, System Code: 722011, System Code: 722027, System Serial Number: 321, 285, 490, 51, 298 +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
The ALLURA Xper FD10/10 is a diagnostic imaging system used in clinical settings to perform X-ray imaging. Hospitals and clinics purchase these systems to support interventional radiology and fluoroscopy workflows.
Why This Is Dangerous
A malfunctioning wired foot switch can prevent X-ray imaging from starting or cause intermittent imaging during procedures. This may disrupt diagnostic or therapeutic workflows.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The device failure can cause procedural delays and potential diagnostic inaccuracies, affecting patient care in busy radiology suites.
Practical Guidance
How to identify if yours is affected
- Check System Code on the device for 722005, 722011, or 722027
- Review recall notice for distribution details and affected units
Where to find product info
Manufacturer recall letters, FDA notice, device labels on the imaging system
What timeline to expect
Remediation timelines are not specified in the recall. Expect communications from Philips with next steps.
If the manufacturer is unresponsive
- Document all attempts to contact Philips and healthcare providers
- Escalate to hospital risk management or procurement teams
- File a formal complaint with the FDA if the device remains unaddressed
How to prevent similar issues
- Verify recalls during vendor communications and asset management checks
- Ensure devices in service have updated firmware and are part of recalled units
- Maintain an inventory of all system codes and serial numbers for quick verification in future recalls
Documentation advice
Keep recall communications, photos of device labels, serial numbers, purchase records, and correspondence with Philips or healthcare providers.
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Product Details
Product: ALLURA Xper FD10/10 imaging system System Codes: 722005, 722011, 722027 Quantity recalled: 112 units Distribution: Domestic nationwide in the United States; International distribution in Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Côte d’Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 112 total units recalled
- Distributed nationwide in the US and internationally
- X-ray imaging may fail to initiate or intermittently stop when using the wired foot switch
- No injuries or incidents reported
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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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