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, ELDERLY
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
- Medical Imaging System or Diagnostic System (Allura Xper FD10/10)
- Model numbers
- 722005, 722011, 722027, UDI-DI 00884838059047, 00884838054196
- 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 FD10/10 is a diagnostic imaging system used in clinical settings for X-ray based procedures.
Why This Is Dangerous
A BIOS battery that depletes sooner than expected can prevent the system from starting, potentially delaying diagnostic imaging.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate halt could halt imaging procedures, potentially affecting patient care and workflow.
Practical Guidance
How to identify if yours is affected
- Verify model numbers 722005, 722011, or 722027.
Where to find product info
Refer to the recall notice and manufacturer documentation for UDI, serial number, and model information.
What timeline to expect
Remediation or replacement guidance will be provided by Philips; expect timelines to be communicated with the recall notice.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a report with the FDA if applicable
- Request a documented remediation plan from Philips
How to prevent similar issues
- For future purchases, verify BIOS battery reliability and defect history for critical medical devices
- Follow manufacturer firmware and battery health guidelines
- Have a formal recall response protocol in health care facilities
Documentation advice
Keep copy of the recall notice, correspondence with Philips, serial numbers, model numbers, UDI-DI, and any replacement or remediation receipts.
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Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- 585 total units recalled worldwide
- 145 units in the US, 440 outside the US
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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