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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Interventional Imaging System
- Model numbers
- Product Code: 722038, UDI-DI: 00884838054226, Serial numbers: 39,63,42,55,67,99,60,71,115,78,106,118,130,49,119,126,173,37
- Sold at
- Unknown
- 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 FD20/20 is a dedicated interventional imaging system used in cath labs for X-ray guided procedures.
Why This Is Dangerous
Deterioration in certain internal parts can stop motorized movements, potentially complicating procedures, while still enabling manual operation and imaging.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Immediate use restrictions for facilities with affected units; potential workflow disruption and scheduling impacts.
Practical Guidance
How to identify if yours is affected
- Check product code 722038 and UDI 00884838054226
- Confirm recall date 2025-09-03 and status ACTIVE
Where to find product info
Manufacturer recall notice and FDA enforcement report linked in the provided source
What timeline to expect
Refunds or repairs typically coordinated through Philips; no explicit timeline provided in data
If the manufacturer is unresponsive
- Escalate to healthcare facility compliance department
- Consult FDA enforcement action page for guidance
- Document all communications
How to prevent similar issues
- Maintain current service agreements with Philips
- Regularly review FDA recall databases
Documentation advice
Retain recall notices, service reports, serial list
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Allura Xper FD20/20; Product Code: 722038. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Quantity: 75 units (26 US, 49 outside US). Distribution: Worldwide. Recall date: 2025-09-03. Status: Active.
Reported Incidents
No specific incidents or injuries are reported in the provided data.
Key Facts
- 75 units recalled (26 US, 49 outside US)
- CMOS battery, hard disk drive, or power supply deterioration identified
- Motorized movements may fail; X-ray imaging remains available
- Worldwide distribution across many countries
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.