Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems Nederland
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Product type
- Medical Imaging System
- Model numbers
- 722003, 722010, 722026
- 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 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
Allura Xper FD10 is a medical imaging system used in interventional radiology to guide procedures. Hospitals purchase these units for advanced imaging during cardiac and vascular interventions.
Why This Is Dangerous
A BIOS battery that depletes faster than expected can prevent the system from starting. There are no user alerts prior to power depletion, delaying diagnosis of the issue.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may face unexpected downtime and service disruptions, potentially delaying patient procedures and requiring temporary equipment substitution.
Practical Guidance
How to identify if yours is affected
- Check model numbers against 722003, 722010, 722026.
Where to find product info
Check device label, service records, or hospital inventory system for model, serial, and UDI codes.
What timeline to expect
Remediation timelines vary by site; expect several weeks to coordinate replacement or service.
If the manufacturer is unresponsive
- Document all outreach attempts to Philips and the hospital’s risk management team.
- If necessary, file concerns with appropriate health authorities and maintain records of communications.
How to prevent similar issues
- Register for recall alerts from Philips and FDA.
- Maintain current inventory logs with model, serial, and UDI codes.
- Establish a clear escalation path with hospital engineering and risk management.
Documentation advice
Keep copies of recall notices, correspondence with the manufacturer, service reports, and serial/UDI documentation for each device.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2,317 total units recalled (US 497; international 1,820)
- Broadcast distribution: Worldwide
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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