ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 4056869063317 Serial Numbers: 180550 180517 180518 180546 180547 180560 180534 180556 180537 180545 180533 180566 180536 180563
- 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 a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
- 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 biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
Product Codes/Lot Numbers:
UDI-DI: 4056869063317 Serial Numbers: 180550 180517 180518 180546 180547 180560 180534 180556 180537 180545 180533 180566 180536 180563
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2359-2023
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.