Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems Nederland
- 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
- Product type
- Biplane Angiography System
- Model numbers
- 722008, 722013
- 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 FD20 Biplane is an interventional radiology imaging system used during catheter-based vascular or neuro interventions. It relies on a BIOS battery to boot. The battery controls startup sequencing.
Why This Is Dangerous
If the BIOS battery depletes, startup cannot proceed and the device may not power on. The recall notes that no user messages appear before power depletion.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Hospitals may experience procedure delays or rescheduling due to startup failures. The immediate safety impact is the potential for a non-operational imaging system during critical procedures.
Practical Guidance
How to identify if yours is affected
- Check model numbers 722008 or 722013.
- Verify UDI-DI for the affected unit (722013 has 00884838059061).
Where to find product info
Serial numbers and UDI-DI are on the device nameplate and service records.
What timeline to expect
Next steps will be communicated by letter from Philips; replacement or remediation timelines will be provided at that time.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Consult FDA for guidance on post-recall actions
How to prevent similar issues
- Ensure ongoing device inventory and recall tracking in hospital systems
- Maintain service agreements with imaging suppliers
- Verify device firmware and battery monitoring features as available
Documentation advice
Keep the recall letter, model and serial numbers, and all correspondence with Philips and hospital administration.
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Product Details
Model Numbers: 722008; 722013 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563 Serial numbers affected (sample): 491, 489, 360, 325, 142, 125, 312, 319, 82, 192, 244, 453, 306, 116, 124, 18270 UDI-DI: 722008 N/A; 722013 00884838059061 Quantity: 501 units (212 US, 289 outside US) Distribution: Worldwide distribution to US nationwide and many countries Recall date: 2025-09-03 Brand: Philips Medical Systems Nederland B.V. (standardized as Philips Medical Systems Nederland) Product type: Allura Xper FD20 Biplane Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 501 units recalled (US: 212; outside US: 289)
- Model numbers 722008 and 722013
- Hazard: BIOS battery depletion halts startup with no user warning
- No injuries or incidents reported to date
- Recall method: Written notification (letter) to healthcare facilities
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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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