FDAFDA · Food and drugs·Recall number Z-1782-2013
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Published July 31, 2013 · Recall initiated: June 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
Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution and Puerto Rico
- Lot
- Model numbers: 10094137, 10094139, 10094141, 10280959
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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