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
- Interventional Radiology Imaging System
- Model numbers
- 722001, 722003
- 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 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
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 FD10C is a medical imaging system used in interventional radiology. It assists physicians in conducting vascular and neurological procedures.
Why This Is Dangerous
A BIOS battery that depletes faster than expected can stop the system from starting, potentially delaying patient imaging.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals may need to halt procedures until an update or replacement is arranged, which can affect patient throughput and scheduling.
Practical Guidance
How to identify if yours is affected
- Check model number 722001 on the device label
- Review internal asset registry for device status
Where to find product info
Recall notices are posted on FDA enforcement pages and the Philips recall communications portal.
What timeline to expect
Recall resolution timelines vary; hospitals typically expect guidance within weeks to months for replacement or service.
If the manufacturer is unresponsive
- Escalate to hospital procurement or biomedical engineering
- File a formal recall complaint with the manufacturer and FDA if needed
- Consult legal counsel if patient procedures are affected by delays.
How to prevent similar issues
- Verify device firmware and battery health during procurement
- Maintain an up-to-date asset registry with serial numbers
- Monitor for recall updates from the manufacturer and FDA
Documentation advice
Document all communications with the sponsor and any fault reports; preserve device labels and serials for audit.
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Product Details
Model number: 722001. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Sold worldwide; 2 units recalled in the US. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2 units recalled (US only)
- BIOS battery depletion halts startup
- No user warning before depletion
- Global distribution noted in notice
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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