Recall Z-1445-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis Q/ Q zen systems; Artis Q/ Q zen systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiograp
| Date | Apr 14, 2015 (initiated Mar 19, 2015) |
| Status | Terminated |
| Reason | potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected. |
| Root cause | Employee error |
| Action | A customer notification, dated March 19, 2015, was distributed to all affected customer via AX018/15/S. Additionally, Siemens has initiated an inspection of Artis Q/ Q zen systems via Update Instruction AX017/15/S. |
| Quantity | 139 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123529 | ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Feb 26, 2013 |