Recall Z-2108-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is 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.
| Date | Apr 22, 2020 |
| Status | Terminated |
| Reason | If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer |
| Root cause | Software design |
| Action | Siemens issued Urgent Medical Device Correction dated 4/22/20 via AX074/19/S. 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 correct the error with a software patch in which the system will recognize a deviation of the intended travel path and unit movements are stopped im |
| Quantity | 105 systems |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |