SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 75708 75765 75714 75790 75709 75607 75784 75789 75617 75550 75526 75512 75775 75567 75536 75807 75711 75716 75514 75770 75600 75794 75563 75824 75768 75510 75792 75454 75754 75755 75540 75739 75806 75808 75571 75818 75437 75500 75527 75776 75728 75475 75535 75820 75727 75481 75439 75450 75482 75760 75710 75460 75476 75588 75493 75458 75528 75467 75823 75761 75602 75487 75804 75837 75743 75787 75793 75478 75604 75805 75513 75532 75843 75555 75788 75524 75778 75515 75559 75610 75501 75570 75769 75774 75752 75799 75616 75750 75576 75845 75605
  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:
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system

Product Codes/Lot Numbers:

Serial Numbers: 75708 75765 75714 75790 75709 75607 75784 75789 75617 75550 75526 75512 75775 75567 75536 75807 75711 75716 75514 75770 75600 75794 75563 75824 75768 75510 75792 75454 75754 75755 75540 75739 75806 75808 75571 75818 75437 75500 75527 75776 75728 75475 75535 75820 75727 75481 75439 75450 75482 75760 75710 75460 75476 75588 75493 75458 75528 75467 75823 75761 75602 75487 75804 75837 75743 75787 75793 75478 75604 75805 75513 75532 75843 75555 75788 75524 75778 75515 75559 75610 75501 75570 75769 75774 75752 75799 75616 75750 75576 75845 75605

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1748-2018

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