Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053
  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:
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

Product Codes/Lot Numbers:

UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1246-2022

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