Recall Z-2029-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
| Date | May 27, 2021 |
| Status | Open, Classified |
| Reason | Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system |
| Root cause | Software design |
| Action | Siemens issued a Urgent Medical Device Correction Letter on 5/27/21 via AX064/20/S. Additionally, a software solution is being distributed via Update Instruction AX063/20/S to all affected customers. Letter states reason for recall, health risk and action to take: Planned procedures may have to be terminated and performed on an alternative X-ray system. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will update the affected so |
| Quantity | 116 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |