Siemens AG/Siemens Healthcare GmbH Recall 94892
Description: ARTIS 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.
Siemens AG/Siemens Healthcare GmbH Recall 94892 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-2241-2024 |
| Event ID | 94892 |
| Event Description | ARTIS 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. |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC. |
| Quantity | 201 units in total |
| Recall Reason | A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user. |
| Device Classification | 20240710 |
| Device Code Info | ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325 |
| Center Classification Date | 20240702 |
| Recall Initiation Date | 20240626 |
| Recalling Firm | Siemens AG/Siemens Healthcare GmbH |
| Initial Notification | Letter |
| Similar To |