Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips
- 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
- Product type
- Imaging system
- Model numbers
- 722010, 722026, 722003, 00884838059030, 00884838054189
- 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 FD10 is an interventional imaging system used for fluoroscopy in clinical procedures. The recall affects systems that rely on motorized movement to position components during imaging.
Why This Is Dangerous
If internal components deteriorate, motorized positioning may become unavailable, which could complicate procedures. Manual movements remain available, and imaging functionality is preserved.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals must stop using affected devices and coordinate with the manufacturer for replacement or remediation. The impact includes potential procedure delays and equipment downtime.
Practical Guidance
How to identify if yours is affected
- 1. Verify device model numbers against 722010, 722026, 722003.
- 3. Inspect for signs of internal component deterioration if available.
- 4. Stop using affected devices and follow manufacturer instructions.
- 5. Contact Philips or the healthcare provider for next steps.
What timeline to expect
Recall processes typically take weeks to months. The notice does not specify replacement timelines.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital administration and regulatory bodies if needed.
- Consult FDA or local health authorities for guidance on unresponsive manufacturers.
How to prevent similar issues
- Stay current with manufacturer recalls and firmware/service updates.
- When purchasing imaging systems, verify robust service support and recall response plans.
Documentation advice
Retain the recall letter, maintain device serials, keep service records, and log communications with the manufacturer and hospital administration.
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Product Details
Model numbers: 722010, 722026, 722003. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Sold worldwide, including 252 US units and 865 outside the US. Sold date and price information not provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1117 total units recalled (252 US, 865 outside US)
- Hazard: deterioration of CMOS battery, HDD, or PSU may disable motorized movement
- Imaging (X-ray) remains available
- Recall date: 2025-09-03; Notice date: 2025-10-01; Status: ACTIVE; 510(k) numbers: K102005, K130842,K
- Classification: Class II; Hazard level: HIGH
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Safety Guide
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