AXIOM Artis MP, Model Number 5904466

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 20334 20052 20303 20238 20242 20322 20282 20363 20338 20295 20348 20172 20264 20367 20258 20265 20250 20249 20281 20243 20339 20321 20294 20254
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
Reason for Recall:
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

AXIOM Artis MP, Model Number 5904466

Product Codes/Lot Numbers:

Serial Numbers: 20334 20052 20303 20238 20242 20322 20282 20363 20338 20295 20348 20172 20264 20367 20258 20265 20250 20249 20281 20243 20339 20321 20294 20254

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2014-2019

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During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

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During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

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