Recall Z-0807-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Dec 20, 2019 |
| Status | Terminated |
| Reason | The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred. |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019. |
| Quantity | 6 |
| Distribution | US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |