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, 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
- Imaging/Monitoring System
- Model numbers
- 722006, 722012, 722028
- 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 FD20 is a medical imaging system used in clinical settings for diagnostic procedures. It provides critical imaging capabilities in hospital environments.
Why This Is Dangerous
A rapidly depleting BIOS battery can prevent system startup without prior user alerts, potentially delaying patient imaging.
Industry Context
This recall is not presented as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate cessation of use is required. Hospitals must coordinate with Philips for guidance. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Identify device as Allura Xper FD20
- Check model numbers 722006, 722012, 722028
Where to find product info
Refer to manufacturer letters and FDA recall page for details on identifiers
What timeline to expect
Refund/replacement timelines not specified; follow manufacturer instructions
If the manufacturer is unresponsive
- Escalate through hospital risk management
- Contact FDA or local medical device regulator
How to prevent similar issues
- Verify battery management and firmware update practices for imaging devices
- Maintain updated service contracts with OEM for battery health checks
Documentation advice
Document recall notice, correspondence with Philips, and any replacement steps
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. Model numbers: 722006, 722012, 722028. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 5,067 units (1,626 US, 3,441 international). Distribution: Worldwide.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- 5,067 total units recalled
- US units: 1,626; international: 3,441
- Hazard: BIOS battery depletion halts start-up with no prior user warning
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.