HIGH

Philips Allura Xper FD20 Recall Affects 2,114 Units Globally Over Power Component Deterioration

Philips Medical Systems Nederland B.V. recalls 2,114 Allura Xper FD20 imaging systems sold worldwide after reports that internal components may deteriorate. The recall covers models 722012, 722028 and 722006 with associated 510(k) numbers K102005 and K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. If deterioration occurs, motorized movements may fail. Manual and imaging功能s,

Quick Facts at a Glance

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

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

Allura Xper FD20 is a ceiling- or floor-mounted imaging system used in interventional radiology to guide procedures.

Why This Is Dangerous

Internal component deterioration may disable motorized system movements, potentially affecting procedural control. Manual positioning remains possible and imaging continues.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Facilities may face downtime and need to coordinate with Philips for equipment replacement or service; safety remains due to potential movement loss.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers on the system label: 722012, 722028, 722006.
  2. Cross-check with associated 510(k) numbers.
  3. Review FDA recall page for Z-2626-2025.

Where to find product info

Manufacturer recall notices and FDA enforcement page. Look for serial plates on the device.

What timeline to expect

Remedies will be provided by Philips; no clear replacement timeline in the summary.

If the manufacturer is unresponsive

  • Escalate with FDA
  • Document all communications
  • Consider legal counsel if needed

How to prevent similar issues

  • Monitor for early degradation indicators during maintenance
  • Ensure backup imaging workflows and downtime protocols
  • Verify service support availability for imaging systems
  • Keep an updated list of affected devices in facilitys asset management

Documentation advice

Record model numbers, recall notices, service tickets, and communications with Philips.

Product Details

Product: Allura Xper FD20 imaging system. Models: 722012, 722028, 722006. Other identifiers: 00884838059054, 00884838054202. Quantity: 2114 units (791 US, 1323 OUS). Sold Worldwide. Recall Date: 2025-09-03. Status: Active. Manufacturer: Philips Medical Systems Nederland B.V. Distribution: Worldwide.

Reported Incidents

No specific incident counts are provided in the summary. The hazard level is listed as HIGH.

Key Facts

  • 2,114 total units recalled (791 US, 1,323 outside US)
  • Models: 722012, 722028, 722006
  • Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K
  • 041949
  • Recall Date: 2025-09-03
  • 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
GENERALPREGNANTPETS
Injury Types
ELECTRICALLACERATIONOTHER

Product Details

Model Numbers
722012
722028
722006
00884838059054
00884838054202
Affected States
ALL
Report Date
October 1, 2025
Recall Status
ACTIVE

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