FDAFDA · Food and drugs·Recall number Z-2108-2013
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Published September 4, 2013 · Recall initiated: April 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Distribution including the states of PA, NJ, DC, VA, MD and DE.
- Lot
- Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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