Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 135954 136032 136077 136043 136190 136197 136168 136143 136234 136383 136242 136393 136128 136147 136350 136256 136314 136548 136550 136557 136558 137165 137119 136607 137388 137231 137471 137591 137245 137369 137347 137329 137391 137479 137425 124006 138061 137461 137518 137567 137582 137667 137595 137656 138104 138190 124116 137714 124119 138012 138070 138017 138058 138194 138156 138214 138128 138180 138188 138260 138268 138311 138259
  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:
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

Product Codes/Lot Numbers:

Serial Numbers: 135954 136032 136077 136043 136190 136197 136168 136143 136234 136383 136242 136393 136128 136147 136350 136256 136314 136548 136550 136557 136558 137165 137119 136607 137388 137231 137471 137591 137245 137369 137347 137329 137391 137479 137425 124006 138061 137461 137518 137567 137582 137667 137595 137656 138104 138190 124116 137714 124119 138012 138070 138017 138058 138194 138156 138214 138128 138180 138188 138260 138268 138311 138259

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1894-2019

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 β†’
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 β†’

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 β†’