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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips Medical Systems Nederland B.V.
- Product type
- Radiology/Imaging System
- Model numbers
- Product Code: 722031, Serial numbers: 155,150,87,88,109,97,138,86,152,135,153,35,76,133,173,124,92,166
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 3, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The Allura CV20 is a medical imaging system used in radiology to perform X-ray scans. It supports both motorized and manual adjustments depending on configuration.
Why This Is Dangerous
Internal component deterioration could cause loss of motorized movement, potentially impacting workflow but imaging remains possible.
Industry Context
This recall is part of ongoing monitoring of medical imaging systems for reliability of internal power and control components.
Real-World Impact
Hospitals may experience downtime in automated positioning, potentially affecting throughput and staff workflow.
Practical Guidance
How to identify if yours is affected
- Identify Product Code 722031 on the device label
- Review recall letter from the manufacturer
Where to find product info
Recall letter and FDA enforcement report Z-2635-2025; product packaging and device label
What timeline to expect
Recalls initiated in 2025 with ongoing guidance; replacement timelines depend on manufacturer arrangements
If the manufacturer is unresponsive
- Escalate to hospital procurement or biomedical engineering
- Contact FDA or national regulatory bodies for guidance
- Document all communications and requests
How to prevent similar issues
- Verify component reliability on similar imaging systems before purchase
- Engage with OEM for service plan covering critical components
- Monitor for early signs of component deterioration in power or storage units
Documentation advice
Keep recall letter, serial list, service agreements, and communications with Philips as records
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Product Details
Product: Allura CV20. Product Code: 722031. Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Quantity: 46 units (OUS only). Distribution: Worldwide, including US nationwide and numerous countries listed. Status: Active as of 2025-10-01.
Reported Incidents
No specific injuries or incidents are detailed in the provided document.
Key Facts
- 46 units recalled (OUS)
- Worldwide distribution including US and numerous countries
- Deterioration of CMOS battery, HDD, PSU potentially disabling motorized movements
- Imaging (X-ray) still available
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Safety Guide
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