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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: Interventional Fluoroscopic X-Ray Systems Recalled for Coolant Failure

Agency Publication Date: April 18, 2024
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Summary

Siemens Medical Solutions USA, Inc. has recalled approximately 583 units of Artis zee, Q, and Q.zen Interventional Fluoroscopic X-ray systems because the coolant level in the cooling circuit can drop below safe levels. If the coolant is too low, the X-ray tube will not be sufficiently cooled, causing the system to display a 'TUBE HOT, have a break' message and stop functioning. This failure can lead to the sudden cancellation of clinical treatments or require patients to be moved to alternative systems mid-procedure.

Risk

The cooling system failure prevents the X-ray tube from operating, which can lead to treatment delays or the need to stop a medical procedure already in progress, potentially impacting patient care.

What You Should Do

  1. Identify if your facility uses any of the following Siemens Artis models: Artis zee (floor, ceiling, multi-purpose, biplane, or MN models), Artis zeego, Artis Q (floor, ceiling, biplane, or zeego), or Artis Q.zen (floor, ceiling, or biplane).
  2. Check your system's UDI-DI or Model Number against the affected list: Artis zee floor (10094135 / 4056869010045), Artis zee ceiling (10094137 / 4056869010052), Artis zee multi-purpose (10094139 / 4056869010076), Artis zee biplane (10094141 / 4056869010069), Artis zeego (10280959 / 4056869010083), Artis Q floor (10848280 / 4056869009971), Artis Q ceiling (10848281 / 4056869009988), Artis Q biplane (10848282 / 4056869009995), Artis Q zeego (10848283 / 4056869010007), Artis Q.zen floor (10848353 / 4056869010014), Artis Q.zen ceiling (10848354 / 4056869010021), Artis Q.zen biplane (10848355 / 4056869010038), Artis zee floor MN (10094142 / 4056869010090), and Artis zee biplane MN (10094143 / 4056869010106).
  3. If you encounter a 'TUBE HOT, have a break' message on your system, be prepared to transition to an alternative system or cancel the clinical treatment as the system cannot be operated normally in this state.
  4. Contact Siemens Medical Solutions USA, Inc. at their Malvern, PA headquarters or through your local service representative to discuss maintenance or repair of the cooling circuit.
  5. Healthcare providers should contact the manufacturer or the FDA for further instructions regarding the continued use of these devices.
  6. For additional information, contact the FDA Medical Device Recall hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

System maintenance for cooling circuit

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

Affected Products

Product: Artis zee floor
Model / REF:
10094135
UPC Codes:
4056869010045
Product: Artis zee ceiling
Model / REF:
10094137
UPC Codes:
4056869010052
Product: Artis zee multi-purpose
Model / REF:
10094139
UPC Codes:
4056869010076
Product: Artis zee biplane
Model / REF:
10094141
UPC Codes:
4056869010069
Product: Artis zeego
Model / REF:
10280959
UPC Codes:
4056869010083
Product: Artis Q floor
Model / REF:
10848280
UPC Codes:
4056869009971
Product: Artis Q ceiling
Model / REF:
10848281
UPC Codes:
4056869009988
Product: Artis Q biplane
Model / REF:
10848282
UPC Codes:
4056869009995
Product: Artis Q zeego
Model / REF:
10848283
UPC Codes:
4056869010007
Product: Artis Q.zen floor
Model / REF:
10848353
UPC Codes:
4056869010014
Product: Artis Q.zen ceiling
Model / REF:
10848354
UPC Codes:
4056869010021
Product: Artis Q.zen biplane
Model / REF:
10848355
UPC Codes:
4056869010038
Product: Artis zee floor MN
Model / REF:
10094142
UPC Codes:
4056869010090
Product: Artis zee biplane MN
Model / REF:
10094143
UPC Codes:
4056869010106

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94299
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc
Manufactured In: United States
Units Affected: 583 units
Distributed To: Nationwide

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.