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
- 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 B.V.
- Product type
- Fluoroscopy System
- Model numbers
- 722011, 722027, 722005
- 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 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 FD10/10 is a fluoroscopy system used in interventional radiology to perform X-ray guided procedures. It is distributed to hospitals and clinics worldwide.
Why This Is Dangerous
Internal components may deteriorate over time, causing loss of motorized movement. The imaging function remains accessible, but automated positioning may fail, impacting procedural workflow.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals must assess inventory and service continuity. Device downtime could delay procedures and complicate operating room scheduling.
Practical Guidance
How to identify if yours is affected
- Check device labels for model numbers 722011, 722027, 722005.
- Cross-check with 510(k) numbers listed in the recall notice.
- Compare device components for signs of CMOS battery, HDD, or PSU deterioration.
Where to find product info
Serial numbers and model identifiers are on the device data plate and user manuals.
What timeline to expect
Vendor will provide replacement or repair instructions; processing timelines depend on facility procurement.
If the manufacturer is unresponsive
- Escalate to hospital risk management or compliance office.
- Contact national medical device authorities if the manufacturer is unresponsive.
How to prevent similar issues
- Implement routine checks on CMOS battery, HDD, and PSU in imaging systems.
- Establish recall notification procedures with suppliers for critical equipment.
Documentation advice
Document device model, serial number, recall notice date, communications with manufacturer, and any downtime impact.
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Product Details
Product: Allura Xper FD10/10 fluoroscopy system. Models: 722011, 722027, 722005. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Sold worldwide to hospitals and clinics, including 67 US units and 219 outside the US. Recall date: 2025-09-03. Country of origin: Netherlands.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 286 total units recalled (67 US, 219 outside US)
- Hazard: deterioration of CMOS battery, HDD, PSU could disable motorized movements
- Imaging (X-ray) function remains available
- Status: ACTIVE (Class II recall)
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Safety Guide
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