Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Nos. 3417 3414 3415 3418 3428 3416
  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:
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).

Product Codes/Lot Numbers:

Serial Nos. 3417 3414 3415 3418 3428 3416

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0805-2021

Related Recalls

MAMMOMAT Inspiration;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →

MAMMOMAT Fusion;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →

MAMMOMAT Revelation;

Siemens Medical Solutions USA

Class I - Dangerous

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Oct 24, 2025 Other Medical Devices Nationwide View Details →