HIGH

Philips Medical Systems Recalls X-ray Imaging Systems Due to Malfunction Risk

Philips Medical Systems Netherlands B.V. recalled 1,117 X-ray imaging systems on September 3, 2025. The recall affects product codes 722010, 722026, and 722003 due to potential internal component deterioration. This issue may render motorized movements inoperable, posing a risk to patient care.

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 Philips X-ray imaging systems with product codes 722010, 722026, and 722003. These systems were distributed worldwide, including 252 units in the U.S. and 865 units internationally. The devices were distributed across multiple countries.

The Hazard

The systems may not perform as intended due to the deterioration of internal components such as the CMOS battery, hard disk drive, and power supply unit. If these components fail, motorized movements will become unavailable, potentially affecting patient imaging and care.

Reported Incidents

The recall does not specify any reported injuries or deaths associated with this issue. However, the high hazard level indicates a risk that could compromise patient safety.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Philips Medical Systems or your healthcare provider for further instructions and follow the recall instructions provided.

Contact Information

For more information, contact Philips Medical Systems at their official website. The recall notification method is via letter.

Key Facts

  • Recall effective September 3, 2025
  • 1,117 X-ray systems recalled
  • Inoperable motorized movements pose risk
  • Manual movements and imaging still functional
  • Immediate cessation of use recommended
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
722010
722026
722003
00884838059030
00884838054189
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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