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: 722005, System Product Name: Allura Xper FD10/10, UDI-DI: N/A, Serial Numbers: 93, 269, 530, 306, 307 +9 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 FD10/10 is a medical imaging system used in healthcare settings for diagnostic purposes. Healthcare providers rely on these systems for accurate imaging to assist in patient diagnosis and treatment.
Why This Is Dangerous
The hazard arises when the drip tray beneath the cooling unit is not installed correctly. This oversight can lead to coolant leaking and potentially contacting electrical components, resulting in dangerous short-circuits.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a limited number of devices, but the potential for electrical failure could compromise patient safety and lead to system outages in medical facilities.
Practical Guidance
How to identify if yours is affected
- Verify the model number as Allura Xper FD10/10, Model Number: 722005.
- Check the serial numbers against the list provided by Philips for affected units.
- Look for any documentation regarding previous field corrections related to the device.
Where to find product info
Serial numbers and model information can typically be found on the device's label or user manual.
What timeline to expect
Expect a processing timeline of 4-6 weeks for refunds or replacements after contacting Philips.
If the manufacturer is unresponsive
- Document your communication attempts with Philips.
- Reach out to your healthcare provider for assistance in the recall process.
- Report the issue to the FDA if you do not receive a response.
How to prevent similar issues
- Always check for recall information before purchasing medical devices.
- Ensure that devices are properly maintained and inspected for safety compliance.
- Consult with healthcare providers about the safety records of medical devices.
Documentation advice
Keep copies of all correspondence with Philips, including emails and letters, along with any receipts related to the purchase of the device.
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Product Details
The recalled product is the Allura Xper FD10/10, Model Number: 722005. It was distributed worldwide, including the US and various countries. The quantity recalled is 14 units.
Key Facts
- Recalled product: Allura Xper FD10/10
- Hazard: Electrical short-circuit risk
- Recall date: December 15, 2025
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Safety Guide
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