FDAFDA · Food and drugs·Recall number Z-2569-2014
Artis zee and Artis zeego systems. x-ray, angiographic system
Published October 1, 2014 · Recall initiated: June 5, 2014
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
There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution
- Lot
- running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers .
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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