What is being recalled?

Siemens Artis Pheno image-intensified fluoroscopic X-ray systems, model No. 10849000, are being recalled for limited system movements after startup.

How many units are affected?

20 units are affected by this recall nationwide in the United States.

Which devices are affected?

Artis Pheno fluoroscopic X-ray systems with the listed serial numbers and UDI are affected.

What should I do if I own one of these devices?

Stop using the device immediately and follow the manufacturer's recall instructions.

Who is issuing the recall?

Siemens Medical Solutions USA is issuing the recall, with notification by recall letter.

Where can I find the recall notice?

The recall notice is published by the FDA enforcement page linked in the recall data.

Are there any reported injuries?

No injuries or incidents have been reported to date.

Will I receive a refund or replacement?

Remedy information is provided by the manufacturer. Check the recall notice for instructions on remedy options.

How long does the recall process take?

Timeline varies by facility and device. Hospitals should coordinate with Siemens for resolution timelines.

What information will I need to identify my device?

Model number, serial number, and UDI should be verified against the recall list.

Where can I find serial numbers and the UDI?

Serial numbers and the UDI are located on the device nameplate and documentation.

Who can I contact for more information?

Contact Siemens Medical Solutions USA according to the recall notice.

HIGHAugust 12, 2025

Siemens Artis Pheno Fluoroscopic X-Ray System Recalled for 20 Units in 2025

Siemens Medical Solutions USA is recalling 20 Artis Pheno image- intensifiied fluoroscopic X-ray systems distributed nationwide. The recall cites limited system movements after startup. Hospitals and healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.

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

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

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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
Check serial numbers against 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011
Confirm UDI 04056869046877
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.

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

20 units recalled
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
Model No. 10849000; Serial Nos: 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164X

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

4/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeImage-Intensified Fluoroscopic X-Ray System

Product Details

Dec 5, 2025

Siemens Medical Solutions USA

A potential