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
- Operating Table (Medical Imaging/Interventional)
- Model numbers
- 722059, UDI-DI 00884838059122
- 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
The Allura Xper system is used for interventional imaging in cath labs and ORs. The table supports patient positioning during procedures.
Why This Is Dangerous
A BIOS battery that depletes too quickly can prevent the system from starting, with no prior warnings to users.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Facilities face potential delays and must remove affected tables from service until remediation.
Practical Guidance
How to identify if yours is affected
- Check model number on the unit label: 722059
- Review serial numbers: 7, 33, 35, 40, 38, 41, 37, 2
- Confirm recall number Z-0011-2026 on FDA site
Where to find product info
Recall notices and contact details via FDA enforcement page and Philips provider channels
What timeline to expect
Remedy timelines set by manufacturer; notification by mail
If the manufacturer is unresponsive
- Escalate to hospital's risk management
- File a CPSC complaint if manufacturer is unresponsive
- Consult hospital legal team for remediation timelines
How to prevent similar issues
- Register device with Philips for recall notifications
- Keep serial numbers and UDI handy for future recalls
Documentation advice
Document all communications and store recall notices with device label photos
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Product Details
Model: Allura Xper FD20/15 OR Table, Model Number: 722059. Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Distribution: Worldwide. Units: 8 (2 US, 6 outside US). UDI-DI: 00884838059122. Serial numbers: 7, 33, 35, 40, 38, 41, 37, 2.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 8 units recalled (2 US, 6 international)
- Model 722059 with UDI-DI 00884838059122
- High hazard level; BIOS battery depletion halts system start-up
- No injuries reported to date
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Safety Guide
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