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Philips Allura Xper FD10F Recall for 10 Units Worldwide (2026)

Philips Medical Systems Nederland B.V. recalls 10 Allura Xper FD10F imaging systems sold to hospitals worldwide. The devices may fail to start X-ray imaging or start intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and contact Philips for instructions.

Official notice
Philips Medical Systems Nederland B.V.Health & Personal CareMedical DevicesSystem Code: 722002System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 3, 2026
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    March 3, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. 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

  1. Verify System Code 722002 on the device label.
  2. Check System Serial Numbers against 53, 61, 78, 38, 28, 63, 3, 81, 66, 40.
  3. 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)

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
System Code: 722002
System Serial Number: 53, 61, 78, 38, 28, 63, 3, 81, 66, 40
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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