Quick Facts at a Glance
- Recall Date
- March 3, 2026
- Hazard Level
- HIGH
- Brand
- Philips
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Product type
- X-ray Imaging System
- Model numbers
- (1) System Code: 722008, (2)722013, System Serial Number: 360, System Serial Number: 361, System Serial Number: 445, System Serial Number: 296, System Serial Number: 487, System Serial Number: 390 +12 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 3, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
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 Biplane is a interventional radiology imaging system used in hospitals for fluoroscopy and X-ray procedures. It is distributed to healthcare facilities worldwide.
Why This Is Dangerous
The wired foot switch can fail to initiate X-ray imaging or may do so intermittently, potentially delaying or interrupting imaging during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals must halt use of affected devices, which could disrupt scheduling and patient care during procedures, and may require reallocation of imaging resources.
Practical Guidance
How to identify if yours is affected
- Check System Code on the device label for 722008 or 722013.
- Cross-check with Philips recall notification and internal asset records.
Where to find product info
System Code and System Serial Numbers are printed on the device labeling and service documentation. The recall notice is posted by the FDA and Philips.
What timeline to expect
Recall processing and remediation may take several weeks. Expect guidance on replacement or repair within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with Philips and hospital leadership.
- Escalate to hospital compliance or risk management if the supplier is slow to respond.
- Consider notifying regulatory authorities if critical delays occur.
How to prevent similar issues
- Establish a recall monitoring process for imaging equipment.
- Verify recall status during procurement and commissioning of new systems.
Documentation advice
Keep copies of recall notices, communications, serial-number lists, and internal escalation logs for audits and insurance purposes.
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Product Details
Model numbers: (1) System Code: 722008; (2)722013. System Serial Numbers: 360, 361, 445, 296, 487, 390, 306, 178, 420, 267, 245, 2470, 491, 113, 386, 69, 413, 365. Sold to healthcare facilities nationwide and internationally. Domestic US distribution: 198 units. International distribution: 263 units. Price: Not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Units recalled: 461 total (198 US, 263 OUS)
- Distribution: Nationwide in the US; International in 70+ countries
- Hazard level: HIGH
- Remedy: Stop using and follow manufacturer instructions; recall notification by letter
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Safety Guide
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