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Philips Medical Systems Nederland recall 296 Allura Xper FD20/15 Imaging Systems Over Foot Switch Fl

Philips Medical Systems Nederland B.V. recalls 296 Allura Xper FD20/15 imaging systems distributed nationwide and internationally after reports the wired foot switch may fail to initiate imaging or start intermittently. The defect can delay X-ray imaging in patient care. Healthcare providers and patients should stop using the device and follow recall instructions from the manufacturer.

Official notice
Philips Medical Systems Nederland B.V.Health & Personal CareMedical DevicesSystem Code 722058UDI 00884838059115System Serial Number 100

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 imaging system
Model numbers
System Code 722058, UDI 00884838059115, System Serial Number 100, 239, 305, 259, 203, 373 +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

Allura Xper FD20/15 is a fluoroscopy-enabled imaging system used in hospitals for interventional procedures.

Why This Is Dangerous

A malfunction with the wired foot switch can prevent or delay imaging initiation, impacting patient care.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Delays in imaging can affect diagnosis and treatment planning in time-sensitive settings.

Practical Guidance

How to identify if yours is affected

  1. Check System Code 722058 on the device label
  2. Look for System Serial Number 100

Where to find product info

Recall letter from Philips and device labels for identifiers

What timeline to expect

Refund or replacement timelines are not specified; expect manufacturer instructions.

If the manufacturer is unresponsive

  • Escalate to hospital safety officer
  • Document all communications
  • File a complaint with the manufacturer and regulatory bodies if needed

How to prevent similar issues

  • Verify device identifiers before deployment
  • Monitor recall notices from manufacturers
  • Maintain a log of recall communications

Documentation advice

Retain recall letters, take photos of labels, log dates of communications, save correspondence

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Product Details

Model and identifiers: System Code 722058; UDI 00884838059115; System Serial Number 100; Additional model identifiers listed as 239, 305, 259, 203, 373, 111, 38, 23, 290, 124, 274, 340, 366, 162, 186, 4, 196. Sold through nationwide distribution in the U.S. and internationally to numerous countries. Recall date: 2026-03-03. Status: ACTIVE. Quantity: 296 units (68 US, 228 international). Price range: Unknown. Country of origin: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • System Serial Number 100
  • Issue: foot switch can fail to initiate imaging or do so intermittently

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 722058
UDI 00884838059115
System Serial Number 100
239
305
+15 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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