HIGH

Philips Medical Systems Nederland recalls 5 Allura Xper FD20/20 OR Tables for BIOS battery startup

Philips Medical Systems Nederland B.V. recalls 5 Allura Xper FD20/20 OR Tables (Model 722039) worldwide. The BIOS battery may deplete faster than designed, halting startup with no warning. Hospitals should stop using the affected devices and follow recall instructions from Philips.

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
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

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 FD20/20 OR Table is used in operating room workflows to support patient positioning during procedures. It is designed to integrate with imaging and ancillary equipment.

Why This Is Dangerous

A BIOS battery that depletes prematurely can prevent the system from starting, potentially delaying procedures and requiring device removal from service until resolved.

Industry Context

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

Real-World Impact

Hospitals may need to substitute equipment or reschedule procedures. The recall aims to prevent nonfunctional equipment from entering service.

Practical Guidance

How to identify if yours is affected

  1. Confirm model 722039 and UDI-DI 00884838054271 on the device label.
  2. Verify serial numbers 2, 4, 5, 6, or 8 are present on the unit.
  3. Check recall notice for instructions specific to your facility.

Where to find product info

Recall notice and FDA enforcement page. Manufacturer contact is listed in the recall communications.

What timeline to expect

Refunds/replacements or service actions typically take 4-8 weeks after submission of request.

If the manufacturer is unresponsive

  • Escalate with hospital risk management or regulatory authorities.
  • Document all communications with the manufacturer.
  • Consider filing a complaint with the FDA if the device remains nonfunctional or unsafe.

How to prevent similar issues

  • Verify battery-backed systems during procurement
  • Confirm device firmware and power management are validated by the manufacturer
  • Maintain a risk register for critical medical devices and monitor recall notifications

Documentation advice

Keep the recall letter, device identifiers, serial numbers, and correspondence with the manufacturer. Photograph labels and store any replacement documentation.

Product Details

Product: Allura Xper FD20/20 OR Table Model numbers: 722039 Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563 Serial numbers: 2, 4, 5, 6, 8 UDI-DI: 00884838054271 Quantity: 5 units (OUS only) Sold worldwide: US nationwide and listed countries; worldwide distribution Recall date: 2025-09-03 Manufacturer: Philips Medical Systems Nederland B.V. (Netherlands) Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 5 units recalled
  • Model 722039
  • UDI-DI 00884838054271
  • 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563
  • Recall date 2025-09-03
  • Worldwide distribution (US and many countries)

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
722039
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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