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Philips Medical Systems Issues Recall for Allura Xper FD10/10

Philips Medical Systems recalled 21 units of the Allura Xper FD10/10 system on December 15, 2025. A defect in the drip tray could cause coolant to contact electrical components, posing a high risk of electrical short-circuits. Users should stop using the device immediately and follow recall instructions.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesModel Number: 722011System Product Name: Allura Xper FD10/10UDI-DI: 00884838059047

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 15, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 15, 2025
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
Medical Imaging System
Model numbers
Model Number: 722011, System Product Name: Allura Xper FD10/10, UDI-DI: 00884838059047, Serial Numbers: 268, 205, 213, 89, 293 +12 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 15, 2025

  2. Reported by FDA DEVICE

    January 21, 2026

  3. RecallRadar source check

    January 28, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

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 FD10/10 is a medical imaging system used in healthcare settings for diagnostic purposes. It is designed to provide high-quality images for various medical assessments.

Why This Is Dangerous

The defect involves a missing or improperly installed drip tray, which is supposed to catch coolant. Without it, there is a risk of coolant leaking onto electrical components, which could lead to dangerous short-circuits.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must refrain from using the device, which could disrupt medical services. The recall is a precautionary measure to prevent potential electrical hazards.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device to see if it is 722011.
  2. Verify if the device has a drip tray properly installed beneath the cooling unit.
  3. Contact Philips Medical Systems for confirmation if uncertain.

Where to find product info

The model number and serial numbers can usually be found on the back or bottom of the device.

What timeline to expect

Expect a timeline of 4-6 weeks for refund or replacement processing.

If the manufacturer is unresponsive

  • Document your attempts to contact Philips.
  • Follow up with a second request via email or phone.
  • Consider filing a complaint with the FDA if no response is received.

How to prevent similar issues

  • Always check for product recalls before purchasing medical devices.
  • Look for devices that have clear safety certifications.
  • Consider alternatives with a strong safety record.

Documentation advice

Keep records of your purchase, any communications with Philips, and any relevant medical records.

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Product Details

The recalled product is the Allura Xper FD10/10, Model Number 722011. It was distributed worldwide, including the United States and several other countries. No retail price is mentioned.

Key Facts

  • Potential electrical short-circuit hazard
  • Contact Philips for instructions
  • Recall initiated on December 15, 2025

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
ELECTRICAL

Product Classification

Product Details

Model Numbers
Model Number: 722011
System Product Name: Allura Xper FD10/10
UDI-DI: 00884838059047
Serial Numbers: 268
205
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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