Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Artis Pheno X-Ray Systems Recalled for Startup Movement Defects

Agency Publication Date: September 5, 2025
Share:
Sign in to monitor this recall

Summary

Siemens Medical Solutions USA, Inc. has initiated a voluntary recall of 20 units of the Artis Pheno Image-Intensified Fluoroscopic X-Ray System (Model No. 10849000). The recall was issued following reports that the system may experience limited or restricted physical movements after startup. This issue can disrupt medical procedures and affects specific serial numbers distributed across multiple states.

Risk

The limited system movement can interfere with the device's ability to position correctly for imaging, which may cause delays or interruptions during clinical and surgical procedures. No injuries have been reported in the recall data.

What You Should Do

  1. This recall affects 20 units of the Artis Pheno Image-Intensified Fluoroscopic X-Ray System, specifically Model Number 10849000 with UDI 04056869046877.
  2. To determine if your system is affected, locate the serial number on the device label and compare it to the list of 20 recalled units. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Siemens Medical Solutions USA, Inc. or your equipment distributor to arrange for a return, replacement, or on-site correction of the system.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Artis Pheno Image-Intensified Fluoroscopic X-Ray System
Model / REF:
10849000
Serial Numbers:
164184
164183
164071
164072
164027
164026
164094
164019
164161
164152
164069
164086
164084
164158
164188
164105
164080
164011
164100
164097
UDI:
04056869046877

Limited system movements after startup.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97444
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Authorized Medical Device Distributors; Siemens Medical Solutions USA, Inc.
Manufactured In: United States
Units Affected: 20 units
Distributed To: Alabama, Arizona, Florida, Kentucky, Massachusetts, Michigan, New York, Oregon, Pennsylvania, Tennessee, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.