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: 722029, System Product Name: Allura Xper FD20/10, UDI-DI: 00884838054219, Serial Numbers: 30, 81, 80, 47
- 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 FD20/10 is a medical imaging system used in healthcare facilities for cardiovascular procedures. It is chosen for its advanced imaging capabilities and efficiency in diagnosis and treatment.
Why This Is Dangerous
The hazard arises when the drip tray beneath the cooling unit is not installed, allowing coolant to leak and potentially contact electrical parts. This can lead to electrical shorts, risking system failures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a small number of devices, but it is crucial for the safety of patients and healthcare providers. Immediate action is necessary to prevent potential electrical hazards.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device to see if it is 722029.
- Look for any notification letters from Philips regarding this recall.
- Contact your healthcare provider for confirmation of your device's status.
Where to find product info
The model number and serial numbers can typically be found on the back or bottom of the device.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after the return.
If the manufacturer is unresponsive
- If you do not receive a response from Philips, try contacting them again.
- Reach out to your healthcare provider for assistance in getting information.
How to prevent similar issues
- Always check for recall notices on medical devices before use.
- Be aware of any unusual functions or warnings from the device.
Documentation advice
Document all communications with the manufacturer and keep records of the recall notice.
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Product Details
The recall affects Allura Xper FD20/10 systems with Model Number 722029. The recalled units were distributed globally, including the US and 47 other countries. This issue involves four units.
Key Facts
- Recall date: December 15, 2025
- Quantity recalled: 4 units
- High hazard level
- Global distribution including US
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Safety Guide
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