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
- Fluoroscopy System
- Model numbers
- System Code: 722029, UDI: 00884838059078, System Serial Number: 57, 7, 88, 56, 126, 94 +12 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 FD20/10 is an interventional radiology fluoroscopy system used in hospitals for real-time X-ray imaging during procedures.
Why This Is Dangerous
A wiring foot switch may fail to initiate X-ray imaging or operate intermittently, potentially disrupting procedures and imaging continuity.
Industry Context
This recall is not presented as part of a broader industry-wide pattern in the provided data.
Real-World Impact
Hospitals may experience imaging delays or interruptions during procedures, affecting workflow and patient care.
Practical Guidance
How to identify if yours is affected
- Identify System Code 722029 on the device label.
- Check UDI 00884838059078 for verification.
- Review System Serial Numbers listed in the recall documentation.
Where to find product info
Recalls are published on the FDA enforcement page and through Philips communications to healthcare facilities.
What timeline to expect
Philips will coordinate remediation with facilities; timelines vary by site.
If the manufacturer is unresponsive
- Escalate to hospital risk management or biomedical engineering.
- File inquiries with FDA recall processes if needed.
How to prevent similar issues
- Monitor for recall notices from Philips and FDA.
- Maintain up-to-date service agreements and software updates where applicable.
Documentation advice
Keep the recall letter, correspondence with Philips, service orders, and incident reports related to the device.
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Product Details
Model/Identification: System Code 722029; UDI 00884838059078; System Serial Number 57. Quantity: 85 units (20 US, 65 outside the US). Distribution: Domestic nationwide; Internationally to 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, Côte d’Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, 2
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 85 total units recalled (20 US, 65 international)
- System Code 722029 and UDI 00884838059078
- Intermittent or no X-ray initiation with wired foot switch
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Safety Guide
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