HIGH

Philips Recalls Biplane OR Table Due to Component Deterioration

Philips Medical Systems Nederland B.V. recalled five Biplane OR Tables on September 3, 2025, due to potential failure of internal components. The recall affects models 722020 and 722025, distributed worldwide. Users must stop using the affected devices immediately to avoid operational issues.

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 recall involves Allura Xper FD20 Biplane OR Tables with product codes 722020 and 722025. The devices have associated 510(k) numbers including K102005 and K130842. They were sold worldwide, including the US, and the quantity recalled is five units.

The Hazard

The 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 occurs, motorized movements will become unavailable.

Reported Incidents

No specific incidents or injuries have been reported related to this recall, but the potential for operational failure poses a high risk.

What to Do

Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Philips Medical Systems for further guidance.

Contact Information

For more information on the recall, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2629-2025. Alternatively, contact Philips Medical Systems Nederland B.V.

Key Facts

  • Recall date: September 3, 2025
  • Quantity recalled: 5 units
  • Affected models: 722020, 722025
  • Global distribution
  • Class II medical device
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
722020
722025
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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