HIGH

Philips Medical Systems Recalls Imaging Systems Over Malfunction Risk

Philips Medical Systems Nederland B.V. recalled 268 Allura Xper FD20 Biplane systems on September 3, 2025. The recall affects units distributed globally due to potential failures in internal components. If malfunction occurs, motorized movements will be disabled, posing risks to operational efficiency.

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

Product Details

The recalled product includes Allura Xper FD20 Biplane systems with product codes 722013 and 722008. The recall involves 268 units, with 102 sold in the U.S. and 166 distributed internationally.

The Hazard

The imaging systems may fail to perform as intended due to the deterioration of internal components such as the CMOS battery, hard disk drive, and power supply unit. If this happens, motorized movements of the system will be unavailable, which could impact patient care.

Reported Incidents

No specific incidents or injuries have been reported in relation to this recall. The risk remains high due to the potential for operational failure.

What to Do

Stop using the recalled imaging systems immediately. Contact Philips Medical Systems for further instructions and follow the provided recall guidelines.

Contact Information

For more information, call Philips Medical Systems at 1-800-XXX-XXXX or visit their website at www.philips.com.

Key Facts

  • Recall date: September 3, 2025
  • Report date: October 1, 2025
  • 268 units recalled
  • Class II device
  • Worldwide distribution
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
722013
722008
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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