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: 722003, System Product Name: Allura Xper FD10, UDI-DI: N/A, Serial Numbers: 1232, 967, 746, 1276, 232 +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 for diagnostic purposes. It provides advanced imaging capabilities for various medical evaluations.
Why This Is Dangerous
Coolant leakage from an improperly installed drip tray can lead to contact with electrical components, creating a risk of electrical short circuits and potential system failures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate action from healthcare providers to ensure patient safety and prevent potential equipment failure during medical procedures.
Practical Guidance
How to identify if yours is affected
- Verify the model number as 722003.
- Check if the drip tray is installed correctly.
- Look for any documentation from previous field corrections.
Where to find product info
The model number and serial numbers can typically be found on the device's back panel or manufacturer's label.
What timeline to expect
Expect a resolution or guidance from Philips within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Philips through their customer service line.
- Document all communication attempts for your records.
How to prevent similar issues
- Ensure all medical devices are regularly checked for compliance with safety standards.
- Request documentation of any field corrections from manufacturers before accepting devices.
Documentation advice
Keep all relevant communication, product receipts, and any service records as proof of ownership and for potential claims.
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Product Details
The recall affects Allura Xper FD10 systems with model number 722003. These units were distributed worldwide, including the U.S. and countries such as Australia, Brazil, and the United Kingdom.
Key Facts
- Potential for coolant leakage
- Risk of electrical short circuits
- Immediate action required
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