Quick Facts at a Glance
- Recall Date
- August 12, 2025
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- 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
- Siemens Medical Solutions USA
- Product type
- Image-Intensified Fluoroscopic X-Ray System
- Model numbers
- 10849000, 164184, 164183, 164071, 164072, 164027, 164026, 164094 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 12, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Limited system movements after startup .
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
Artis Pheno is a fluoroscopic imaging system used in interventional radiology to guide procedures. Hospitals commonly use it for real-time X-ray visualization during complex interventions.
Why This Is Dangerous
The defect is limited system movements after startup. This could affect device performance during imaging procedures and compromise safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and providers must stop using affected devices and coordinate with Siemens for instructions. The recall involves 20 units and may affect patient procedures during imaging guidance.
Practical Guidance
How to identify if yours is affected
- Verify device model number 10849000
- Verify device was distributed nationwide in the listed states
Where to find product info
Look up the recall notice and the manufacturer's instructions. The FDA enforcement page provides recall details.
What timeline to expect
Remedies are coordinated by the manufacturer. Expect recall-related actions to take several weeks to complete, depending on facility readiness.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- Escalate to hospital risk management
- Consult the FDA’s recall process if the company is slow to respond
How to prevent similar issues
- Vet devices for recalls before procurement
- Verify UDI, serial number, and model against recall lists before installation
- Maintain an up-to-date device recall monitoring process
Documentation advice
Keep the recall letter, correspondence with the manufacturer, and any device records. Document device status and actions taken.
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Product Details
Model No. 10849000; UDI 04056869046877; Serial Nos. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011; Distribution: US nationwide in AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX, UT; Sold to hospitals and healthcare facilities; Recall Date: 2025-08-12; Status: ACTIVE; Hazard Level: HIGH; Remedy: Stop using and follow manufacturer instructions.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: Siemens Medical Solutions USA
- Product: Artis Pheno image‑intensified fluoroscopic X‑ray system
- Hazard: Limited system movements after startup
- Distribution: Nationwide in AL, AZ, FL, KY, MA, MI, NY, OR, A, TN, TX & UT
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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