FDAFDA · Food and drugs·Recall number Z-2395-2016
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of 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 with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
Published August 17, 2016 · Recall initiated: July 13, 2016
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 possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam
- Lot
- Model Numbers:10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, 7728392
- 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.