AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392
- 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 possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Product Codes/Lot Numbers:
Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0603-2017
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