What models are affected by this recall?

Models 722023, 722035, and 722015 of the Allura Xper FD20 OR Table are affected.

What should a hospital do if it has one of these tables?

Stop using the device immediately. Follow the recall instructions and contact Philips Medical Systems Nederland B.V. or the hospital's provider for guidance.

Are there any injuries reported related to this recall?

No injuries or incidents have been reported in connection with this recall.

What is the hazard associated with these tables?

Deterioration of the CMOS battery, hard disk drive, and/or power supply unit can disable motorized movements, potentially affecting OR workflow.

How many units are involved in the recall?

174 units are included, with 45 in the United States and 129 outside the United States.

What is the recall date?

The recall date is 2025-09-03, with the report dated 2025-10-01.

Who is issuing the recall?

Philips Medical Systems Nederland B.V. is issuing the recall.

What copy of the recall notice should facilities follow?

Facilities should follow the manufacturer’s recall instructions as communicated to them via notice. Contact Philips or their healthcare provider for further steps.

Where can I find more information about this recall?

Refer to the FDA enforcement page for Z-2628-2025 and Philips' official communications.

Will there be a repair or replacement available?

The remedy instructs to stop use and follow recall instructions. The specific remedy details should be provided by Philips or a healthcare provider.

HIGHSeptember 3, 2025

Philips Allura Xper FD20 OR Table Recalled for 174 Units Worldwide in 2025

Philips Medical Systems Nederland recalled 174 Allura Xper FD20 OR Tables worldwide, including 45 in the United States. The devices may deteriorate internally, rendering motorized movements inoperable. Hospitals and clinics should stop using the 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
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 OR Table is an operating room table integrated with Philips imaging equipment. Hospitals use it to position patients for surgical procedures and imaging.

Why This Is Dangerous

Internal component deterioration can stop motorized movements, potentially complicating patient positioning during procedures. Manual movements and imaging capabilities may remain available, but full functionality is compromised.

Industry Context

This recall is not identified as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals must halt use of affected tables until they receive recall instructions. The recall involves 174 units, implying significant institutional impact and potential care-delivery delays.

Practical Guidance

How to identify if yours is affected

Verify model numbers 722023, 722035, 722015 on the device data plate
Cross-check the device against the recall list and 510(k) numbers
Review manufacturer recall notice for instructions

Where to find product info

Recall documents and enforcement page; device data plate; hospital biomedical engineering records

What timeline to expect

Remediation timelines are not specified; institutions should coordinate with Philips or authorized service providers and expect an enterprise-level, 4

If the manufacturer is unresponsive

Escalate to hospital compliance or regulatory authorities
Document all communications and seek escalation channels

How to prevent similar issues

Verify recall status before commissioning new OR tables
Ensure service is performed by approved technicians
Maintain an up-to-date asset registry with model numbers and recall status

Documentation advice

Keep recall letter, communications from manufacturer, and all service records. Photograph serial labels and data plates for documentation.

Product Details

Product: Allura Xper FD20 OR Table Model numbers: 722023, 722035, 722015 Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949 Sold at: Worldwide distribution to healthcare facilities US sales: 45 units; International sales: 129 units Recall date: 2025-09-03 Manufacturer: Philips Medical Systems Nederland B.V. (Netherlands) Price: Not disclosed Notes: 174 total units recalled; Distribution includes United States and 120+ other countries

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Total recalled units: 174
US units: 45; International units: 129
Model codes: 722023, 722035, 722015
Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Imaging Equipment

Product TypeOperating Room Table

Product Details

Sep 3, 2025

Philips Medical Systems Nederland

The BIOS