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
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 room table (X-ray/fluoroscopy)
- Model numbers
- 722033
- Sold at
- Multiple Retailers
- 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 FD10 OR Table is an operating room imaging table used in interventional radiology to support patient positioning during procedures. The recall concerns a BIOS battery that can deplete, preventing startup and halting crucial system functions.
Why This Is Dangerous
A depleted BIOS battery can stop the system from starting without warning. This interruption can delay imaging and treatment in time-sensitive procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may experience procedure delays and must halt use of the affected equipment until recall actions are completed. Hospitals may incur downtime costs and require temporary substitutes.
Practical Guidance
How to identify if yours is affected
- Verify device model 722033 on Allura Xper FD10 OR Table.
- Check UDI-DI 00884838059078 and Serial Number 1 as listed in the recall data.
- Confirm receipt of recall notification by mail.
- If affected, stop using the device immediately and follow manufacturer instructions.
Where to find product info
UDI-DI, Serial Number, and recall notifications are part of the device record and FDA recall notices.
What timeline to expect
Remedies and timelines vary by case; not specified in the public notice.
If the manufacturer is unresponsive
- Escalate to hospital risk management and biomedical engineering.
- File a report with the recall authority or regulator if the manufacturer is unresponsive.
How to prevent similar issues
- Verify BIOS battery reliability during equipment procurement and commissioning.
- Monitor recall alerts from the FDA and manufacturer for high-risk medical devices.
- Maintain an updated asset registry with model, serial, and UDI-DI data.
Documentation advice
Keep the recall notification letter, maintain device records, log communications with the manufacturer, and document any downtime and replacements.
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Product Details
Model Numbers: 722033. Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Sold worldwide, including US nationwide and the countries listed in the recall notice. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US and 70+ countries
- BIOS battery risk may halt startup
- Stop use immediately and await recall instructions
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Safety Guide
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