Recall Z-2404-2015 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Aug 18, 2015 (initiated Jun 30, 2015) |
| Status | Terminated |
| Reason | in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system. |
| Root cause | Software design |
| Action | A customer advisory notice, dated June 30, 2015, was sent to consignees informing them of the corrective action that would be performed to prevent the possible loss of the image generation function. Siemens plans to contact end users to install a software patch. For questions regarding this recall call 610-219-6300. |
| Quantity | 586 |
| Distribution | Nationwide Distribution |
| 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 |