HIGH

Philips Allura Xper FD20 Biplane OR Table Recall Affects 5 Units Worldwide (2025)

Philips Medical Systems Nederland B.V. recalled five Allura Xper FD20 Biplane OR Tables distributed worldwide after potential deterioration of the CMOS battery, hard disk drive and power supply could stop motorized movements. Hospitals and clinics should stop using the devices immediately and await manufacturer 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 FD20 is a biplane interventional radiology table paired with an X-ray imaging system used in hospital procedures. It supports motorized positioning and imaging during interventions.

Why This Is Dangerous

Internal components may deteriorate, leading to loss of motorized movement. This can affect positioning during procedures while imaging remains functional.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

The malfunction could disrupt procedures if motorized movement fails. Immediate action is required to prevent patient risk and procedural delays.

Practical Guidance

How to identify if yours is affected

  1. Check if you own Allura Xper FD20 Biplane OR Table with product codes 722020 or 722025.
  2. Review associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949.
  3. Look for labels on the unit that confirm model numbers and 510(k) references.

Where to find product info

Manufacturer recall notice and FDA enforcement report provide model numbers and 510(k) references.

What timeline to expect

No specific timeline is provided for remediation. Expect ongoing manufacturer guidance to be issued by letters or notices.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • If the company is slow to respond, escalate to the facility’s safety officer and consider contacting regulatory authorities.
  • Do not operate the device until guidance is received.

How to prevent similar issues

  • Verify devices before use in critical procedures.
  • Maintain an accurate inventory of high-risk imaging equipment and their recall status.
  • Stay updated with FDA/European authorities for recall notices on medical devices.

Documentation advice

Keep copies of the recall notice, model numbers, 510(k) numbers, serial numbers, purchase records, and all communications with the manufacturer.

Product Details

Brand: Philips Medical Systems Nederland B.V. Product: Allura Xper FD20 Biplane OR Table Product codes: 722020, 722025 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949 Recall date: 2025-09-03 Units recalled: 5 (2 US, 3 outside US) Distribution: Worldwide (US nationwide plus numerous countries listed) Countries of origin: Netherlands

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 5 units recalled total
  • 2 units in the US, 3 units outside the US
  • Product codes 722020 and 722025
  • 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949
  • Recall date: 2025-09-03
  • Status: ACTIVE

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 Classification

Product TypeInterventional Radiology OR Table (Allura Xper FD20 Biplane)
Sold At
Multiple Retailers

Product Details

Model Numbers
722020
722025
Affected States
ALL
Report Date
October 1, 2025
Recall Status
ACTIVE

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