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 Fluoroscopy System
- Model numbers
- System Code: 722002, System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40
- 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 FD10F is a medical fluoroscopy system used in interventional radiology to image the body during procedures.
Why This Is Dangerous
A wired foot switch fault may prevent X-ray imaging from starting or cause intermittent imaging, potentially delaying diagnosis or treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt procedures using the affected systems and arrange for recall-based remediation. No reported injuries to date.
Practical Guidance
How to identify if yours is affected
- Verify System Code 722002 on the device label.
- Check System Serial Numbers against 53, 61, 78, 38, 28, 63, 3, 81, 66, 40.
- Confirm the device is not in active use.
Where to find product info
System Code label and System Serial Number tag on the equipment; UDI is listed as N/A.
What timeline to expect
Recall notice does not specify remediation timeline.
If the manufacturer is unresponsive
- Escalate in-hospital risk management; contact regulatory authorities if appropriate.
- Maintain records of recall communications and device status.
How to prevent similar issues
- Monitor recall communications from Philips and regulatory agencies.
- Verify future equipment recalls before installation.
- Coordinate with procurement to replace or remediate affected systems promptly.
Documentation advice
Document recall notice receipt, serial numbers, and communications with Philips and hospital risk management.
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Product Details
Product: ALLURA Xper FD10F, System Code 722002 Quantity: 10 units (8 US, 2 overseas) Sold in: Domestic nationwide distribution; International distribution to Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Egypt, France, Germany, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Romania, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United Arab Emirates, United States,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 8 in the US, 2 overseas
- Hazard: Intermittent or non-initiation of X-ray imaging when using wired foot switch
- Status: Active (as of recall date)
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Safety Guide
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