Recall Z-1284-2016 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
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
| Date | Mar 31, 2016 (initiated Feb 18, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Siemens sent an Important Customer Safety Notice to customers on February 18, 2016 informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings with metal couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an earlier appointment at 1-800-888-7436. |
| Quantity | 986 systems in total |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073290 | ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc., Feb 11, 2008 |