FDAFDA · Food and drugs·Recall number Z-1284-2016
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is 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 zee/zeego and 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 zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Published April 6, 2016 · Recall initiated: February 18, 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
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.
- Lot
- Serial Numbers: Artis Q Ceiling 109033, 109135, 109141, 109123, 109080, 109074, 109119, 109016, 109118, 109155, 109067, 109066, 109068, 109134, 109133, 109084, 109011, 109096, 109159, 109130, 109143, 109102, 109015, 109144, 109009, 109057, 109108, 109103, 109038, 109040, 109034, 109129, 109137, 109029, 109136, 109064, 109132, 109058, 109145, 109050, 109076, 109007, 109072, 109075, 109071, 109091, 109090, 109041, 109039, 109060, 109146, 109088, 109092, 109032, 109021, 109048, 109020, 109036, 109043, 109161, 109101, 109105, 109104, 109107, 109047, 109031, 109028, 109027, 109120, 109010, 109093, 109157, 109156, 109069, 109158, 109044
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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