HIGHFDA DEVICE

Philips Allura Xper FD20/10 Recall Affects 85 Imaging Systems in 2026

Philips recalled 85 Allura Xper FD20/10 imaging systems distributed nationwide and internationally. The devices may fail to initiate X-ray imaging or do so intermittently when using the wired foot switch. Hospitals and clinicians should stop using the device and follow the manufacturer’s recall instructions.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLANDHealth & Personal CareMedical DevicesSystem Code: 722029UDI: 00884838059078System Serial Number: 57

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
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
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.

  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 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

  1. Identify System Code 722029 on the device label.
  2. Check UDI 00884838059078 for verification.
  3. 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.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Details

Model Numbers
System Code: 722029
UDI: 00884838059078
System Serial Number: 57
7
88
+15 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
MEDIUM

AvKARE Recalls Rosuvastatin Tablets Due to Dissolution Issues

AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.

SUN PHARMACEUTICAL INDUSTRIES
Labeling: Not
Read more