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
- Medical Imaging System Console
- Model numbers
- 722031
- 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 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
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
Allura Xper CV20 is a medical imaging system used in clinical environments. It is valued for diagnostic imaging capabilities.
Why This Is Dangerous
A BIOS battery may deplete faster than designed. This can halt startup without warning, preventing device operation when needed.
Industry Context
This recall is not explicitly described as part of a broader industry pattern.
Real-World Impact
Affects healthcare operations relying on the imaging system; no injuries reported yet but startup failure could disrupt patient care.
Practical Guidance
How to identify if yours is affected
- Check model number 722031
- Confirm distribution status for your facility or region
Where to find product info
FDA recall page Z-0014-2026 and manufacturer communications
What timeline to expect
Not specified; expect manufacturer guidance and potential repair options within weeks
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA via maker recall submission
- Document all communications
How to prevent similar issues
- Maintain updated service agreements with Philips
- Verify device status before use
- Monitor for recall updates from FDA and Philips
- Prepare for potential downtime in clinical workflow
Documentation advice
Keep recall letter, log communications with Philips, maintain device service records
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Product Details
Model Numbers: 722031. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 53 units (OUS only). Distribution: Worldwide, including US nationwide and many countries listed.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- 53 units affected (OUS)
- Worldwide distribution including US and numerous countries
- High hazard level
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Safety Guide
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