FDAFDA · Food and drugs·Recall number Z-2587-2014
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures
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 the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution.
- Lot
- material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.