Quick Facts at a Glance
- Recall Date
- September 3, 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
- Imaging System
- Model numbers
- Product Code: 722029, UDI-DI: 00884838054219, Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
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
Allura Xper FD20/10 is a medical imaging system used in interventional radiology for X-ray guided procedures.
Why This Is Dangerous
Internal component deterioration can disable motorized system movements, potentially impacting procedures. Manual movements and imaging remain available.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt or delay certain procedures requiring motorized positioning while relying on manual adjustments.
Practical Guidance
How to identify if yours is affected
- Verify product code 722029 on the device label.
- Check UDI-DI 00884838054219 on documentation.
- Review the list of serial numbers associated with the recall: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37.
Where to find product info
Look for the device label on the imaging system and the user manuals or vendor communications for the recall notice.
What timeline to expect
Remediation steps are coordinated through Philips and healthcare facilities; users should expect guidance within weeks to months.
If the manufacturer is unresponsive
- Escalate to hospital risk management or biomedical engineering.
- Document all inquiries and responses with Philips or the facility.
- Consider pursuing formal recall channels if the provider is unresponsive.
How to prevent similar issues
- Keep UDI and serial numbers documented for all imaging systems.
- Engage with hospital risk management to ensure timely remediation for affected units.
Documentation advice
Keep all recall notices, serial numbers, and correspondence with Philips and facility records.
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Product Details
Model numbers: Product Code 722029. UDI-DI 00884838054219. Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37. Sold worldwide including US nationwide and 34 other countries. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 11 US, 34 outside US
- CD-encoded serials list
- Class II recall
- High hazard level
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