Recall Z-1846-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego 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 angiogra
| Date | Jun 25, 2015 (initiated May 22, 2015) |
| Status | Terminated |
| Reason | There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported. |
| Root cause | Software design |
| Action | Siemens sent an Important Customer Safety Notice letter dated May 22, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter also informed customers that Siemens would contact them to schedule the installation of a software update to resolve the problem. |
| Quantity | 475 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141574 | ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc., Sep 5, 2014 |