Quick Facts at a Glance
- Recall Date
- September 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems
- 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
- Product type
- Imaging System (Interventional/Diagnostic)
- Model numbers
- 722012, 722028, 722006, 00884838059054, 00884838054202
- 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 is a ceiling- or floor-mounted imaging system used in interventional radiology to guide procedures.
Why This Is Dangerous
Internal component deterioration may disable motorized system movements, potentially affecting procedural control. Manual positioning remains possible and imaging continues.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Facilities may face downtime and need to coordinate with Philips for equipment replacement or service; safety remains due to potential movement loss.
Practical Guidance
How to identify if yours is affected
- Check model numbers on the system label: 722012, 722028, 722006.
- Cross-check with associated 510(k) numbers.
- Review FDA recall page for Z-2626-2025.
Where to find product info
Manufacturer recall notices and FDA enforcement page. Look for serial plates on the device.
What timeline to expect
Remedies will be provided by Philips; no clear replacement timeline in the summary.
If the manufacturer is unresponsive
- Escalate with FDA
- Document all communications
- Consider legal counsel if needed
How to prevent similar issues
- Ensure backup imaging workflows and downtime protocols
- Verify service support availability for imaging systems
- Keep an updated list of affected devices in facilitys asset management
Documentation advice
Record model numbers, recall notices, service tickets, and communications with Philips.
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Product Details
Product: Allura Xper FD20 imaging system. Models: 722012, 722028, 722006. Other identifiers: 00884838059054, 00884838054202. Quantity: 2114 units (791 US, 1323 OUS). Sold Worldwide. Recall Date: 2025-09-03. Status: Active. Manufacturer: Philips Medical Systems Nederland B.V. Distribution: Worldwide.
Reported Incidents
No specific incident counts are provided in the summary. The hazard level is listed as HIGH.
Key Facts
- 2,114 total units recalled (791 US, 1,323 outside US)
- High hazard level
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Safety Guide
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