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: 722038, UDI: 00884838054226, System Serial Number: 71, 115, 42, 108, 173, 119 +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 FD20/20 is an interventional radiology X-ray imaging system used in hospitals to guide procedures.
Why This Is Dangerous
A fault with the wired foot switch can prevent imaging from starting or cause intermittent imaging during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience delays or interruptions in imaging during patient procedures, potentially impacting clinical workflows and patient care.
Practical Guidance
How to identify if yours is affected
- Verify System Code 722038 on the device label
- Check UDI 00884838054226 on the device
- Cross-check against the list of affected units provided by Philips
- Review recall letter once delivered by Philips for further instructions
Where to find product info
Identifiers appear on the device label near the control panel and the model plate; the UDI is also listed in the recall documentation
What timeline to expect
Recall typically involves weeks to months for refunds or replacements, as communicated in the recall letter
If the manufacturer is unresponsive
- Escalate to hospital procurement and risk management
- File a formal recall request with Philips via designated channels
- Consult the FDA recall page for interim guidance
How to prevent similar issues
- Verify device recalls before procurement and installation
- Keep an updated inventory of interventional imaging systems
- Ensure recall communications reach clinical leadership and biomedical engineering
- Regularly review device firmware and service advisories
Documentation advice
Keep the recall letter, device labels showing System Code 722038 and UDI 00884838054226, purchase records, and all correspondence with Philips and hospital risk management
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Product Details
Product: Allura Xper FD20/20 imaging system. System Code: 722038. UDI: 00884838054226. System Serial Numbers: 71 and other listed identifiers (see model list). Quantity: 111 units (31 US, 80 outside the US). Sold nationwide in the United States and internationally in multiple countries. No price data provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 111 total units recalled (31 US, 80 international)
- System Serial Number 71
- Countries listed include Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, and
- Recall date 2026-03-03; status ACTIVE; hazard level HIGH
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Safety Guide
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