HIGH

Philips Recalls 1 Allura Xper FD20/15 OR Table for Movement Failure Risk (2025)

Philips Medical Systems Nederland B.V. recalls 1 Allura Xper FD20/15 OR Table distributed worldwide to hospitals and clinics. The device may lose motorized movements due to deterioration of internal components. Stop using the device and contact Philips for instructions immediately.

Quick Facts at a Glance

Recall Date
September 3, 2025
Hazard Level
HIGH
Brand
Philips
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

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 FD20/15 OR Table is a high-end interventional radiology table used in operating rooms for patient positioning during imaging-guided procedures.

Why This Is Dangerous

Internal component deterioration can disable motorized adjustments, potentially affecting procedural workflow and patient positioning. Manual movements and imaging functions remain available.

Industry Context

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

Real-World Impact

Hospitals may experience disruptions in procedure setup if motorized adjustments fail. The imaging function remains available, which preserves diagnostic capability but could affect workflow.

Practical Guidance

How to identify if yours is affected

  1. Locate the device labeling for Product Code 722059
  2. Check the UDI-DI 00884838059122
  3. Note any serial numbers, listed as 2 in the record
  4. Refer to the recall letter for confirmation

Where to find product info

Recall details are available in the FDA enforcement repository linked in the notice and on Philips recall communications

What timeline to expect

4-8 weeks for recall actions such as replacement or service after instructions are issued

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to hospital risk management or regulatory affairs
  • Contact FDA/other regulators if manufacturer is nonresponsive

How to prevent similar issues

  • Register devices for recall alerts
  • Keep device labeling and serial information accessible
  • Work with the supplier to obtain approved replacement parts
  • Review maintenance schedules for early detection of component wear

Documentation advice

Keep copy of recall letter, serial numbers, UDI, and all communications with the manufacturer and service providers

Product Details

Brand: Philips. Product: Allura Xper FD20/15 OR Table. Product Code: 722059. UDI-DI: 00884838059122. Serial numbers: 2. 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Sold/distributed: Worldwide. Recall date: 2025-09-03. Report date: 2025-10-01. Manufacturer: Philips Medical Systems Nederland B.V. Status: Active. Distribution scope includes US nationwide and many countries listed in the recall notice.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Product Code 722059
  • UDI-DI 00884838059122
  • Serial numbers: 2
  • 510(k) numbers listed
  • Recall date 2025-09-03

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
GENERALPREGNANTELDERLYPREGNANTGENERAL
Injury Types
ELECTRICALOTHER

Product Details

Brand
Model Numbers
Product Code: 722059
UDI-DI: 00884838059122
Serial numbers: 2
Affected States
ALL
Report Date
October 1, 2025
Recall Status
ACTIVE

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