Quick Facts at a Glance
- Recall Date
- March 10, 2026
- Hazard Level
- HIGH
- Brand
- Siemens Medical Solutions USA
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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
- Interventional Radiology Imaging System
- Model numbers
- ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 10, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
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
About This Product
ARTIS pheno and ARTIS Icono are advanced imaging systems used in interventional radiology and diagnostic imaging to visualize internal anatomy with X-ray based guidance.
Why This Is Dangerous
The display may erroneously indicate a high X-ray dose to the patient. The actual dose remains within regulatory limits, but the misrepresentation can affect clinical decisions.
Industry Context
This recall is not part of a broader industry pattern currently disclosed.
Real-World Impact
Facilities may experience workflow disruption and potential need for temporary alternatives while awaiting remediation.
Practical Guidance
How to identify if yours is affected
- Review device UDI numbers to confirm affected models.
- Check recall notice and FDA page for the list of model identifiers.
- Stop using devices immediately per recall guidance.
Where to find product info
Device UID stickers and the manufacturer’s recall communications contain the identifying codes.
What timeline to expect
Remedy procedures will be provided by Siemens after the recall is acknowledged by facilities. Expect weeks to months for replacement or repair.
If the manufacturer is unresponsive
- Escalate with hospital risk management.
- File an official complaint with the manufacturer if needed.
- Refer to FDA enforcement pages for guidance.
How to prevent similar issues
- Verify device dose reporting accuracy during purchases or prior to use.
- Maintain updated firmware and follow vendor recall communications promptly.
Documentation advice
Record device identifiers, recall numbers, and all communications with vendor and risk management.
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Product Details
Brand: Siemens Medical Solutions USA. Product: ARTIS pheno and ARTIS Icono biplane, floor and ceiling imaging systems. Models/UDI: ARTIS pheno UDI 4056869046877; ARTIS Icono biplane UDI 4056869063317; ARTIS Icono ceiling UDI 4056869295923; ARTIS Icono floor UDI 4056869149325. Quantity: U.S. 758; OUS 2077. Distribution: Worldwide including the United States.
Reported Incidents
No specific injuries or incidents are provided in the recall notice. The hazard is a display anomaly related to dose indication.
Key Facts
- ARTIS pheno and ARTIS Icono imaging systems recalled worldwide.
- Total units recalled: 2,835 (U.S. 758, international 2,077).
- Issue: misdisplayed high X-ray dose in patient exams; actual dose remains compliant with settings.
- Manufacturer guidance pending; stop-use advised until instructions are issued.
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Safety Guide
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