HIGH

Philips Medical Systems Recalls Imaging Systems Due to Malfunction Risk

Philips Medical Systems recalled 2,114 Allura Xper FD20 imaging systems on September 3, 2025. The systems may fail due to internal component deterioration, risking loss of motorized functionality. This recall affects 791 units in the U.S. and 1,323 globally.

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 codes include 722012, 722028, and 722006. These systems were distributed worldwide, including the U.S. and countries such as Canada, Germany, and Australia. No price information is available.

The Hazard

The imaging systems may not perform as intended if internal components, such as the CMOS battery or power supply unit, deteriorate. This can lead to loss of motorized movements, although manual movements and imaging capabilities will remain functional.

Reported Incidents

No specific injuries or incidents have been reported connected to this recall. The risk level is classified as high due to potential operational failures.

What to Do

Healthcare providers and patients should stop using the affected devices immediately. Contact Philips Medical Systems for further instructions on the recall process.

Contact Information

For more information, contact Philips Medical Systems Nederland B.V. or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2626-2025.

Key Facts

  • Recall date: September 3, 2025
  • Reported date: October 1, 2025
  • Quantity recalled: 2,114 units
  • Affected U.S. units: 791
  • Affected international units: 1,323
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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
722012
722028
722006
00884838059054
00884838054202
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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