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Philips Medical System Recall Over Electrical Hazard Risk

Philips Medical Systems Nederland B.V. recalled 22 Allura Xper FD10/10 systems on December 15, 2025. The recall stems from a potential electrical hazard due to an improperly installed drip tray. Patients and healthcare providers must stop using these devices immediately.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesModel Number: 722027System Product Name: Allura Xper FD10/10UDI-DI: 00884838054196

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: 722027, System Product Name: Allura Xper FD10/10, UDI-DI: 00884838054196, Serial Numbers: 298, 246, 146, 170, 238 +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 facilities for diagnostic procedures. Healthcare providers rely on this system for accurate imaging during patient evaluations.

Why This Is Dangerous

If the drip tray is not installed correctly, coolant can leak and contact electrical components. This poses a risk of electrical short-circuits that may lead to system failures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers using the Allura Xper FD10/10 may face disruptions in medical imaging services. The recall requires immediate cessation of use, impacting patient care and operational efficiency.

Practical Guidance

How to identify if yours is affected

  1. Check the model number: Allura Xper FD10/10
  2. Verify the serial numbers listed in the recall notice against your device
  3. Look for documentation regarding previous field corrections related to the drip tray

Where to find product info

The model number and serial numbers can typically be found on the product label or user manual.

What timeline to expect

Expect a timeline of 4-8 weeks for refund processing once the recall instructions are followed.

If the manufacturer is unresponsive

  • Document all correspondence with the manufacturer
  • Follow up via phone or email
  • Report to the FDA if issues persist

How to prevent similar issues

  • Ensure products have proper installation documentation
  • Verify product recalls before purchase
  • Consult with healthcare equipment specialists

Documentation advice

Keep records of any correspondence regarding the recall and document the model and serial numbers for reference.

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Product Details

The recalled product is the Allura Xper FD10/10, Model Number: 722027. It has been distributed worldwide, including the US and multiple countries. The quantity recalled is 22 units.

Key Facts

  • Recall date: December 15, 2025
  • Report date: January 21, 2026
  • High hazard level
  • Class II recall

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: 722027
System Product Name: Allura Xper FD10/10
UDI-DI: 00884838054196
Serial Numbers: 298
246
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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