Recall Z-2108-2013 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
| Date | Aug 28, 2013 (initiated Apr 26, 2013) |
| Status | Terminated |
| Reason | The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300. |
| Quantity | 178 |
| Distribution | US Distribution including the states of PA, NJ, DC, VA, MD and DE. |
| 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 |