HIGH

Philips Allura Xper FD10/10 Recall for 286 Units Worldwide in 2025

Philips Medical Systems Nederland B.V. recalled 286 Allura Xper FD10/10 fluoroscopy systems worldwide, including 67 US units. Deterioration of internal components such as the CMOS battery, hard disk drive, and power supply can disable motorized system movements. Hospitals and other healthcare providers should stop using affected devices and follow the manufacturer’s recall instructions.

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

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

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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

  1. Check device labels for model numbers 722011, 722027, 722005.
  2. Cross-check with 510(k) numbers listed in the recall notice.
  3. 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.
  • Adhere to vendor maintenance schedules and firmware updates.
  • 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.

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)
  • Product codes: 722011, 722027, 722005
  • 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949
  • Hazard: deterioration of CMOS battery, HDD, PSU could disable motorized movements
  • Imaging (X-ray) function remains available
  • Status: ACTIVE (Class II recall)

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
722011
722027
722005
Affected States
ALL
Report Date
October 1, 2025
Recall Status
ACTIVE

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