Recall Z-0603-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are 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. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiogra
| Date | Nov 17, 2016 (initiated Nov 1, 2016) |
| Status | Terminated |
| Reason | The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. |
| Root cause | Software in the Use Environment |
| Action | Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken. |
| Quantity | 4,657 systems Worldwide |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052202 | AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Mar 7, 2006 |