Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems
- 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
- Product type
- Interventional Fluoroscopy System (Biplane)
- Model numbers
- 722013, 722008
- 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 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
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 is a biplane interventional X-ray imaging system used in catheter-based procedures. Patients typically undergo imaging-guided interventions in hospital settings. The recall concerns internal components that may degrade over time.
Why This Is Dangerous
If the CMOS battery, HDD, or PSU deteriorate, motorized movements could fail during use. This could disrupt procedures, though manual movements and imaging remain available.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience procedure delays or mechanical interruptions. The issue requires immediate corrective action to ensure patient safety and procedural continuity.
Practical Guidance
How to identify if yours is affected
- Verify device is Allura Xper FD20 Biplane with model numbers 722013 or 722008
- Check recall notice and manufacturer correspondence for confirmation
- Review service history and component status (battery, HDD, PSU) on the device
Where to find product info
Serial numbers and date codes are typically on the device label and in service manuals; follow Philips recall communications for exact identifiers.
What timeline to expect
Immediate action required. Replacement or repair arrangements will be scheduled by Philips; timelines vary by facility and kit availability.
If the manufacturer is unresponsive
- Escalate to hospital risk management and procurement
- Contact Philips support through official channels as provided in recall letter
- File a report with regulatory bodies if the company delays remediation
How to prevent similar issues
- Verify device recalls during procurement of interventional imaging systems
- Ask for recall-clearance documentation before accepting equipment
- Maintain updated service agreements and firmware that support traceability
Documentation advice
Keep copy of recall notice, letters, service tickets, and correspondence with Philips. Document all steps taken and any procedural changes.
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Product Details
Model numbers: 722013, 722008. Sold worldwide, including 102 units in the United States and 166 outside the U.S. Recall date: 2025-09-03. Distributor/manufacturer: Philips Medical Systems Nederland B.V. (Philips). Price: Not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 268 total units recalled (102 US, 166 outside US)
- Model numbers 722013 and 722008
- Cause: deterioration of CMOS battery, HDD, PSU
- Motorized movements may fail; manual movements still available
- Imaging function remains available
- Recall date 2025-09-03; report date 2025-10-01
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Safety Guide
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