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
- Imaging/Diagnostic System (C-arm or fluoroscopy stand)
- Model numbers
- Product Code: 722058, UDI-DI: 00884838059115, Serial numbers: 249, 22, 71, 85, 138, 24 +12 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 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
Allura Xper FD20/15 is a high-end imaging system used in interventional radiology to guide procedures. It supports motorized movement of stands and tables, with X-ray imaging central to operation.
Why This Is Dangerous
If the CMOS battery, HDD, or PSU deteriorates, motorized movements may fail, potentially affecting procedural control. Manual movement and imaging capability are preserved.
Industry Context
This recall is not part of a broader industry pattern reported in the data.
Real-World Impact
Clinicians may face reduced automation during procedures. Imaging remains available, but some movements could be lost, affecting workflow and patient safety.
Practical Guidance
How to identify if yours is affected
- Verify product code 722058 on the unit.
- Confirm recall date 2025-09-03 and that the device is part of worldwide distribution.
Where to find product info
Recall notice is issued via FDA enforcement page Z-2633-2025 and manufacturer notification by letter.
What timeline to expect
Remedy details not fully provided. Expect 4-8 weeks for replacement or repair after action plan is issued.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- Consult当地 regulatory bodies if the manufacturer is slow to respond.
How to prevent similar issues
- Verify new devices are certified and free of open recalls before installation.
- Maintain inventory of serial numbers for rapid recall checks.
- Ask for documented service agreements that include recall support.
Documentation advice
Keep copy of FDA enforcement page, recall letter, serial list, and any clinician notes.
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Product Details
Product: Allura Xper FD20/15, Product Code 722058. 98 units recalled worldwide (23 US, 75 outside the US). Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. Serial numbers include 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109. Recall date 2025-09-03. Report date 2025-10-01. Manufacturer: Philips Medical Systems Nederland B.V.
Reported Incidents
No injury or incident counts provided in the recall documentation.
Key Facts
- Recall date 2025-09-03T05:00:00.000Z
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Safety Guide
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