AXIOM Artis dFA, Model Number 7555373

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 50063 50059 50006 50064 50189 50044 50074 50101 51719 50062 50065 50087 50167 50039 50084 51706 51707 50048 50161 50093 50206 50057 50081 50133 50040 50016 50120 50191 51701 50027 51700 50139 50004 50010 50024 50142 50079 50132 50050
  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 dFA, Model Number 7555373

Product Codes/Lot Numbers:

Serial Numbers: 50063 50059 50006 50064 50189 50044 50074 50101 51719 50062 50065 50087 50167 50039 50084 51706 51707 50048 50161 50093 50206 50057 50081 50133 50040 50016 50120 50191 51701 50027 51700 50139 50004 50010 50024 50142 50079 50132 50050

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2024-2019

Related Recalls

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.

Mar 9, 2026 Other Medical Devices View Details →
Class I - Dangerous

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.

Mar 9, 2026 Other Medical Devices View Details →

ARTIS Pheno VE30A and VE40A, Model 10849000

Siemens Medical Solutions USA

Class I - Dangerous

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.

Mar 12, 2026 Other Medical Devices View Details →