SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model # 10430603 Serial # 74192
- 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:
- Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Product Codes/Lot Numbers:
Model # 10430603 Serial # 74192
Distribution:
Distributed in: MI, NY, CA, KY, ND, NE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2624-2016
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