Quick Facts at a Glance
- Recall Date
- March 3, 2026
- 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
- X-ray imaging system
- Model numbers
- System Code: 722001, System Serial Number: 19, 249, 21, 18661014, 77, 82, 195 +8 more
- Sold at
- Multiple Retailers
- 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 FD10C is a radiography system used in clinical imaging. It is designed to produce X-ray images for diagnostic purposes. The recall concerns a wired foot switch that may fail to initiate imaging or do so intermittently.
Why This Is Dangerous
The defect can prevent imaging from starting or cause imaging to stop unexpectedly. This may delay diagnosis or compromise image acquisition.
Industry Context
This recall is not described as part of a broader industry-wide pattern in the provided information.
Real-World Impact
Immediate device cessation is required. Healthcare facilities may need to replace or service units and manage imaging workflow disruptions.
Practical Guidance
How to identify if yours is affected
- Verify System Code 722001 on the device label.
- Cross-check with the recall notice and FDA page.
- Review the list of serial numbers and associated units if available.
Where to find product info
Recall letters, the FDA recall page, and Philips customer service for device-specific identifiers.
What timeline to expect
Remedies and timelines will be provided by Philips in the recall communications. No specific 4- to 8-week window is stated in the notice.
If the manufacturer is unresponsive
- Document all communications with Philips and the healthcare facility leadership.
- Escalate to hospital risk management and regulatory affairs if the manufacturer is slow to respond.
- Consider reporting to FDA if applicable by jurisdiction.
How to prevent similar issues
- Register devices with recall notices and maintain up-to-date contact information with the manufacturer.
- Implement a protocol to suspend use of devices with known defects until cleared by the manufacturer.
- Keep a log of device serial numbers and locations to aid in rapid recalls.
Documentation advice
Document the recall notice, store all correspondence with manufacturer, and retain device labels showing System Code and serial numbers.
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Product Details
Product: Allura Xper FD10C X-ray imaging system. Model identifiers include System Code 722001 and associated serial numbers listed in the recall notice. Quantity recalled: 15 units (7 in the US, 8 outside the US). Distribution: Domestic nationwide and international across a long list of countries. Manufacturer: Philips Medical Systems Nederland B.V.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 15 total units recalled (7 US, 8 international)
- Global distribution to the US and many international locations
- Hazard: potential non-initiation or intermittent imaging with wired foot switch
- No injuries or incidents reported
- Recall status: ACTIVE
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Safety Guide
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