SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792
  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:
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

Product Codes/Lot Numbers:

UDI/DI 405686901102894792, Material Number 10532746, Serial Number 94792

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1134-2023

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