HIGH

Philips Medical Imaging System Recalled for Motorized Movement Risk

Philips Medical Systems Nederland B.V. recalled 46 imaging systems on September 3, 2025. Deterioration of internal components may lead to loss of motorized movements. Healthcare providers must stop using the systems immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 3, 2025
Hazard Level
HIGH
Brand
Philips Medical Systems Nederland B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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 is the Allura CV20 with Product Code: 722031. It was distributed globally, including the US and countries like Australia, Canada, and Germany. The specific model numbers include various serial numbers, with a total quantity of 46 units.

The Hazard

The imaging systems may not perform as intended due to the deterioration of the CMOS battery, hard disk drive, and/or power supply unit. This deterioration can cause a loss of motorized movements while keeping manual and imaging functionalities operational.

Reported Incidents

There have been no reported injuries or incidents related to this recall. The potential risk involves the loss of motorized movements, which could affect patient care.

What to Do

Stop using the device immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.

Contact Information

For more information, visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2635-2025. Philips Medical Systems can be contacted directly for specific inquiries.

Key Facts

  • Recall date: September 3, 2025
  • 46 units affected
  • High hazard level
  • Global distribution including the US
  • Imaging functionality remains available

Safety Assessment

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

Product Details

Model Numbers
Product Code: 722031
Serial numbers: 155
150
87
88
+14 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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