Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Health & Personal Care
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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 / BIOS battery
- Model numbers
- 722058
- 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 FD20/15 is a medical imaging system used in clinical settings. It helps produce diagnostic images during procedures.
Why This Is Dangerous
A BIOS battery that depletes faster than expected can prevent the system from starting, leaving facilities without diagnostic capability. There is no user-facing warning before failure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics could experience downtime, requiring immediate action to exchange or repair units and maintain patient care.
Practical Guidance
How to identify if yours is affected
- Confirm model 722058 is listed in the recall
Where to find product info
Look at the recall notification letter and FDA enforcement page for final instructions
What timeline to expect
No explicit refund/replacement timeline provided; follow manufacturer guidance
If the manufacturer is unresponsive
- Escalate to facility's risk management
- Engage legal counsel if needed
- Document all communications
How to prevent similar issues
- Verify BIOS reliability during procurement
- Ensure devices have updated BIOS with reliable startup messaging
- Establish recall tracking with serial/UDI databases
Documentation advice
Keep recall letter, model/serial numbers, and replacement receipts
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Product Details
Product: Allura Xper FD20/15. Model Numbers: 722058. Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 300 units (69 US, 231 outside US). Distribution: Worldwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 300 units recalled worldwide (69 US, 231 OUS)
- Model 722058 Allura Xper FD20/15
- BIOS battery depletion may halt startup with no prior alert
- Recall date 2025-09-03; report date 2025-10-08
- Active status; high hazard level
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Safety Guide
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