Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems Nederland
- 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
- Product type
- Fluoroscopy System
- Model numbers
- 722038
- 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 FD20/20 is an interventional radiology fluoroscopy imaging system used for vascular and cardiac procedures. Hospitals rely on it for real-time imaging during invasive interventions.
Why This Is Dangerous
A depleted BIOS battery can halt device startup without warning, preventing imaging and potentially delaying procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the available data.
Real-World Impact
Hospitals may experience procedure delays or rescheduling if affected devices fail to start. Facilities must coordinate downtime and recalls with distributors and clinical engineering teams.
Practical Guidance
How to identify if yours is affected
- Verify model 722038 is present on the unit.
- Check UDI-DI 00884838054226 on the device label.
Where to find product info
Locate the model plate, serial number tag, and UDI on the device or in the product documentation.
What timeline to expect
Recall remedies are typically processed within weeks to months depending on the type of action required (service update or parts replacement).
If the manufacturer is unresponsive
- Escalate to the hospital's recall administrator or risk management.
- Contact the distributor for expedited service or replacement parts.
- Report the issue to the FDA if the manufacturer is nonresponsive.
How to prevent similar issues
- Document device serials and UDI numbers when purchasing imaging systems.
- During procurement, confirm BIOS battery design and availability of update paths.
- Request written service update procedures and installation timelines from the vendor.
Documentation advice
Keep the recall letter, device identifiers, serial numbers, and all correspondence. Document downtime and service visits as part of the medical device record.
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Product Details
Model numbers: 722038. Distribution: Worldwide. Sold: Worldwide through healthcare distributors; 34 units in the United States and 81 units outside the U.S. Recall date: 2025-09-03. UDI-DI: 00884838054226. Serial numbers associated with the recall include 39, 63, 42, 55, 67, 99, 60, 71, 141, 115, 7, 78, 108, 106, 167, 118, 130, 49.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 115 total units recalled
- 34 US and 81 outside US
- Remedy involves stopping use and awaiting manufacturer instructions
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Safety Guide
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