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Philips Allura Xper FD20/10 Recall 45 Units Worldwide in 2025

Philips Medical Systems Nederland B.V. recalls 45 Allura Xper FD20/10 imaging systems worldwide due to internal component deterioration. The CMOS battery, hard disk drive and/or power supply may fail. Motorized movements can become unavailable while imaging remains possible. Stop using the device and follow manufacturer instructions.

Official notice
Philips Medical Systems Nederland B.V.Health & Personal CareMedical DevicesProduct Code: 722029UDI-DI: 00884838054219Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
September 3, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Philips Medical Systems Nederland B.V.
Product type
Imaging System
Model numbers
Product Code: 722029, UDI-DI: 00884838054219, Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 3, 2025

  2. Reported by FDA DEVICE

    October 1, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

Allura Xper FD20/10 is a medical imaging system used in interventional radiology for X-ray guided procedures.

Why This Is Dangerous

Internal component deterioration can disable motorized system movements, potentially impacting procedures. Manual movements and imaging remain available.

Industry Context

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

Real-World Impact

Hospitals may need to halt or delay certain procedures requiring motorized positioning while relying on manual adjustments.

Practical Guidance

How to identify if yours is affected

  1. Verify product code 722029 on the device label.
  2. Check UDI-DI 00884838054219 on documentation.
  3. Review the list of serial numbers associated with the recall: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37.

Where to find product info

Look for the device label on the imaging system and the user manuals or vendor communications for the recall notice.

What timeline to expect

Remediation steps are coordinated through Philips and healthcare facilities; users should expect guidance within weeks to months.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or biomedical engineering.
  • Document all inquiries and responses with Philips or the facility.
  • Consider pursuing formal recall channels if the provider is unresponsive.

How to prevent similar issues

  • Keep UDI and serial numbers documented for all imaging systems.
  • Engage with hospital risk management to ensure timely remediation for affected units.

Documentation advice

Keep all recall notices, serial numbers, and correspondence with Philips and facility records.

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Product Details

Model numbers: Product Code 722029. UDI-DI 00884838054219. Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37. Sold worldwide including US nationwide and 34 other countries. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 11 US, 34 outside US
  • CD-encoded serials list
  • Class II recall
  • High hazard level

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
Product Code: 722029
UDI-DI: 00884838054219
Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37
Affected States
ALL
Report Date
October 1, 2025
Recall Status
ACTIVE

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