Recall Z-1750-2013 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
| Date | Jul 17, 2013 (initiated Jan 31, 2013) |
| Status | Terminated |
| Reason | During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail. |
| Root cause | Device Design |
| Action | Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013. |
| Quantity | 23 |
| Distribution | United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 Siemens Medical Solutions USA, Inc., Jun 18, 2009 |