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: 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.
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 FD10/10 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
- Check the model number: Allura Xper FD10/10
- Verify the serial numbers listed in the recall notice against your device
- 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
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Safety Guide
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