Recall Z-1310-2016 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
| Date | Feb 19, 2016 |
| Status | Terminated |
| Reason | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems. |
| Root cause | Other |
| Action | Siemens mailed out an Important Customer Safety Notice to customers informing them of a corrective action that will be performed to prevent a possible leak in the detector cooling system of Axiom Artis and Artis zee systems. The notice stated the affected plastic couplings will be replaced with metal couplings to prevent fluid leaks. Siemen's service organization will contact each customer to arrange a date to perform the corrective action. Customers asked to call 1-800-888-7436 to schedule an appointment for the corrective action to be implemented. |
| Quantity | 1757 angiography systems |
| Distribution | Nationwide distribution: 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021021 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS Siemens Medical Solutions USA, Inc., Jun 6, 2002 |