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
- Biplane Imaging System
- Model numbers
- Model Number: 722008, System Product Name: Allura Xper FD20 Biplane, UDI-DI: N/A, Serial Numbers: 296, 245, 141, 260, 13 +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 FD20 Biplane is a medical imaging system used for advanced diagnostic procedures. It is commonly utilized in hospitals for cardiac and vascular imaging, making it essential for healthcare providers.
Why This Is Dangerous
The absence of a drip tray can lead to coolant leakage onto electrical components, creating an electrical hazard that may cause system failures during critical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients relying on this imaging system, posing risks during medical procedures while requiring immediate attention to address safety concerns.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device. It should be 722008.
- Verify if your device is among the 18 recalled units.
- Look for any correspondence from Philips regarding the recall.
Where to find product info
The model number and serial numbers can typically be found on the back or bottom of the device, or in the user manual.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks once initiated.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Consider reaching out to regulatory agencies like the FDA for assistance.
How to prevent similar issues
- Always verify the installation of critical components during medical device setup.
- Stay informed about recalls in the medical device field through official channels.
Documentation advice
Keep records of your device's model number, any communications with Philips, and documentation related to the recall.
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Product Details
The recall affects Allura Xper FD20 Biplane systems, model number 722008. These systems were distributed worldwide, including in the U.S. and 50 other countries. The quantity recalled totals 18 units.
Key Facts
- Recall date: December 15, 2025
- 18 units recalled worldwide
- Potential for electrical short circuits
- Immediate action required
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Safety Guide
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