ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
- 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:
- Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Product Codes/Lot Numbers:
UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0523-2024
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