SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Class I - DangerousWhat Should You Do?
- Check if you have this product: SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.
- 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, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Product Codes/Lot Numbers:
SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1558-2016
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