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Philips Medical Device Recalled Due to Electrical Hazard

Philips recalled 95 Allura Xper FD10 systems on December 15, 2025. The recall resulted from missing or improperly documented installation of the drip tray, posing an electrical hazard. Users should stop using the device immediately and follow the manufacturer’s instructions.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesModel Number: 722026System Product Name: Allura Xper FD10UDI-DI: 00884838054189

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: 722026, System Product Name: Allura Xper FD10, UDI-DI: 00884838054189, Serial Numbers: 969, 223, 648, 664, 622 +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 is a medical imaging system used primarily in hospitals and healthcare settings for diagnostic procedures. It provides high-quality imaging for various medical applications.

Why This Is Dangerous

The hazard arises from a missing drip tray which is essential for preventing coolant from contacting electrical components. This failure could lead to electrical shorts, posing risks to both the device and patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects the operational safety of the Allura Xper FD10 imaging systems, potentially leading to system failures. Healthcare providers must act quickly to ensure patient safety and device functionality.

Practical Guidance

How to identify if yours is affected

  1. Verify the model number on the device is 722026.
  2. Check if your device is part of the 95 units recalled.
  3. Look for any notifications or documentation regarding field corrections.

Where to find product info

The model number and serial numbers can be found on the device's identification plate, usually located on the back or bottom.

What timeline to expect

Expect the refund processing to take approximately 4-6 weeks after submitting your request.

If the manufacturer is unresponsive

  • Document all communications with the company.
  • Contact the FDA or relevant regulatory authority for further assistance.

How to prevent similar issues

  • Always check for product recalls before using medical devices.

Documentation advice

Keep records of your device's model number, purchase date, and any correspondence regarding the recall.

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Product Details

The recalled product is the Allura Xper FD10 with Model Number 722026. The recall affects 95 units distributed worldwide, including in the US and several countries across Europe, Asia, and South America.

Key Facts

  • Recall date: December 15, 2025
  • Report date: January 21, 2026
  • 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: 722026
System Product Name: Allura Xper FD10
UDI-DI: 00884838054189
Serial Numbers: 969
223
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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