FDAFDA · Food and drugs·Recall number Z-0172-2014
Artis zee systems x-ray, angiographic system
Published November 20, 2013 · Recall initiated: January 21, 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 Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
- Lot
- model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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