SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077
- 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 table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis. These CT systems can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Product Codes/Lot Numbers:
Serial Numbers: 108054, 108059, 108062, 108069, 108076, 108077
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0713-2018
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