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: 722013, System Product Name: Allura Xper FD20 Biplane, UDI-DI: 00884838059061, Serial Numbers: 601, 230, 370, 27, 320 +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 device used for various diagnostic purposes. Healthcare providers rely on this equipment to ensure accurate and safe imaging for patients.
Why This Is Dangerous
The lack of a properly installed drip tray can allow coolant to leak and contact electrical components. This poses a risk of electrical short-circuits, which can cause the system to shut down unexpectedly.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and providers must stop using the device immediately, potentially disrupting medical services. This poses a safety risk that could lead to diagnostic delays.
Practical Guidance
How to identify if yours is affected
- Check the model number for 722013.
- Inspect the device for the presence of a drip tray beneath the cooling unit.
- Review any correspondence from Philips regarding the recall.
Where to find product info
The model number and serial numbers can typically be found on the device's label or documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing once the device is returned.
If the manufacturer is unresponsive
- Document all correspondence with Philips.
- Reach out to the FDA for guidance on the recall.
- Consider filing a complaint if the response is inadequate.
How to prevent similar issues
- Research safety records of medical devices before purchase.
- Ensure that devices have proper installation documentation.
- Consult healthcare providers about recalls and safety updates.
Documentation advice
Keep records of your purchase, correspondence with Philips, and any images of the device for your safety records.
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Product Details
The recall involves the Allura Xper FD20 Biplane, Model Number 722013. The units were distributed worldwide, including the US and countries such as Argentina, Australia, and Brazil. The recall does not specify a price.
Key Facts
- Class II recall
- Potential electrical hazard
- Immediate action required
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Safety Guide
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