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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.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Medical Solutions USA, Inc: ARTIS icono Ceiling System Recalled for Potential Collision Sensor Malfunction

Agency Publication Date: December 9, 2023
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Summary

Siemens Medical Solutions is recalling 38 ARTIS icono ceiling-configuration fluoroscopic x-ray systems worldwide, including 11 units in the United States. The hardware issue involves collision sensors that may falsely signal an obstacle for up to 30 minutes after the system has been powered on from an overnight shutdown. During this false alarm period, system movement is restricted to a very slow "override" mode without active collision protection, which can make the device temporarily unavailable for critical medical procedures. Siemens is notifying affected facilities by letter to address this hardware defect.

Risk

A false collision signal prevents normal operation and high-speed movement of the medical imaging system, potentially delaying urgent diagnostic or therapeutic procedures. If the override function is used to move the equipment while the sensor is malfunctioning, there is an increased risk of an actual collision because the automatic safety protections are disabled.

What You Should Do

  1. Identify if your facility uses the ARTIS icono (ceiling configuration) Fluoroscopic x-ray system, specifically Model number 11328100 with UDI-DI 04056869295923.
  2. Verify your system's serial number against the list of affected units associated with material number 11328100 provided in the manufacturer's notification letter.
  3. Be aware that if the system has been switched off for a long period (e.g., overnight), the collision sensor may falsely trigger for approximately 30 minutes after startup.
  4. Only use the 'override' function for system movement during this 30-minute window if absolutely necessary, as it operates at very slow speeds and without active collision protection.
  5. Contact your local Siemens Medical Solutions representative or the manufacturer directly at 40 Liberty Blvd, Malvern, Pennsylvania, to discuss the hardware fix and ensure your system is operating safely.
  6. Contact your healthcare provider if you have concerns about how this system's unavailability may have impacted your diagnostic or therapeutic care.
  7. For additional information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and potential hardware correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ARTIS icono (ceiling configuration), Fluoroscopic x-ray system
Model / REF:
11328100
Lot Numbers:
All SN's associated with material number 11328100

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93338
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc
Manufactured In: United States
Units Affected: 38 worldwide, 11 US
Distributed To: Florida, Georgia, Iowa, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, Pennsylvania, Texas

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.