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: 722028, System Product Name: Allura Xper FD20, UDI-DI: 00884838054202, Serial Numbers: 893, 614
- 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 is a medical imaging system used for diagnostic and therapeutic procedures in healthcare settings. Hospitals and medical facilities invest in such systems to provide high-quality imaging for patient care.
Why This Is Dangerous
If the drip tray is not installed, coolant can leak and contact electrical components, which may cause electrical short-circuits that could shut down the system unexpectedly.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers relying on the Allura Xper FD20 may face operational disruptions and potential risks to patient safety due to the electrical hazard.
Practical Guidance
How to identify if yours is affected
- Verify the model number is 722028.
- Check the serial numbers 893 and 614.
- Confirm the installation of the drip tray beneath the cooling unit.
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 refund or replacement processing to take approximately 4-6 weeks after the recall has been finalized.
If the manufacturer is unresponsive
- Document all correspondence with Philips.
- Contact the FDA if delays persist.
- Consider reaching out to healthcare regulatory authorities.
How to prevent similar issues
- Always verify installation of critical components during medical device updates.
- Ensure proper documentation of service and repairs is maintained.
- Stay informed about recalls through official health regulatory channels.
Documentation advice
Keep records of any correspondence with Philips, receipts, and documentation of the device's service history.
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Product Details
The recall involves the Allura Xper FD20 imaging systems, model number 722028. These systems were distributed worldwide, including in the U.S., Argentina, Australia, and many other countries. The affected UDI-DI is 00884838054202, with serial numbers 893 and 614.
Key Facts
- Recall date: December 15, 2025
- Report date: January 21, 2026
- Two units recalled worldwide
- Potential electrical short-circuit hazard
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Safety Guide
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