Recall Z-1272-2014 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
AXIOM Artis Systems Product usage: Artis zee 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.
| Date | Mar 22, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system. |
| Root cause | Device Design |
| Action | Siemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0. |
| Quantity | 37 |
| Distribution | USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA. |
| 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 |