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 Table / Biplane OR Table
- Model numbers
- 722020, 722025, K102005, K130638, K130842, K133292, K141979, K162859 +1 more
- 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 FD20 Biplane OR Table is used in surgical imaging suites to position patients during procedures. It is part of Philips' interventional radiology suite lineup and supports fluoroscopy-based guidance.
Why This Is Dangerous
A BIOS battery deterioration can prevent the system from starting, potentially delaying or interrupting clinical procedures without prior alerts.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may experience delays or need for workarounds when routine startup fails. No injuries are reported yet.
Practical Guidance
How to identify if yours is affected
- Check model numbers 722020 or 722025
- Look for recall notification letter from Philips Medical Systems Nederland B.V.
Where to find product info
Recall details are listed on the FDA enforcement page for recall Z-0007-2026 and in manufacturer notices.
What timeline to expect
Replacement or remedy timelines are not specified; expect direct guidance from Philips via official recall letters.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA District Office or local regulatory body if manufacturer is unresponsive
- Document all communications and preserve the recall letter
How to prevent similar issues
- Establish a recall response protocol with clinical engineering
- Maintain updated service contracts with authorized providers
Documentation advice
Keep the recall notice, model numbers, serial numbers, and all correspondence with the manufacturer. Record procedure impact and any downtime.
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Product Details
Product: Allura Xper FD20 Biplane OR Table. Model numbers: 722020 and 722025. Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Quantity: 4 units (2 US, 2 outside the US). Distribution: Worldwide. Sold around the timeframes associated with the devices' regulatory clearances. Manufacturer: Philips Medical Systems Nederland B.V.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4 units recalled (US: 2, International: 2)
- BIOS battery depletion cited as root cause
- Start-up process halts with no pre-emptive user warning
- Recall date 2025-09-03; report date 2025-10-08
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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