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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
December 15, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
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
- Verify the model number on the device is 722026.
- Check if your device is part of the 95 units recalled.
- 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
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