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: 722001, System Product Name: Allura Xper FD10C, UDI-DI: N/A, Serial Numbers: 166, 181, 153, 274, 296 +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 FD10C is a medical imaging system used primarily in healthcare settings for diagnostic procedures. Healthcare providers rely on this device for accurate imaging to guide treatment decisions.
Why This Is Dangerous
The hazard arises if the drip tray beneath the cooling unit is not installed, which can lead to coolant leaking onto electrical components. This presents a serious risk of electrical shorts, potentially compromising the device's functionality and patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using the Allura Xper FD10C face a high risk of system failure due to potential coolant leaks. Immediate action is necessary to ensure patient safety and prevent operational disruptions.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device to confirm it is the Allura Xper FD10C.
- Look for the serial numbers listed in the recall notice to identify if your unit is affected.
- Verify if the drip tray is properly installed according to the manufacturer's specifications.
Where to find product info
The model and serial numbers are typically located on the identification label on the back or bottom of the device.
What timeline to expect
Expect a response from Philips regarding a refund or replacement within 4-6 weeks after contacting them.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Reach out to your healthcare provider for assistance in the recall process.
- Consider filing a complaint with the appropriate regulatory body, such as the FDA.
How to prevent similar issues
- Ensure that any medical device purchased has proper installation documentation available.
- Verify that the manufacturer follows all safety standards and regulations.
- Regularly review any recall notices related to medical equipment you use.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any notes from phone calls regarding the recall as records.
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Product Details
The recalled product is the Allura Xper FD10C, model number 722001. It was distributed worldwide, including the United States and several countries across Europe, Asia, and South America. Exact serial numbers affected include 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, and 299.
Key Facts
- Recall date: December 15, 2025
- 38 units recalled worldwide
- Potential electrical hazard due to coolant leak
- Immediate stop-use recommended
- Contact manufacturer for next steps
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