HIGH

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.

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

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

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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.
  • Ensure that installation and maintenance records are documented correctly.

Documentation advice

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

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
  • 95 units affected
  • Worldwide distribution

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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