Recall Z-2241-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens AG/Siemens Healthcare GmbH
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.
| Date | Jul 2, 2024 (initiated Jun 26, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Inform customers of the temporary workaround to mitigate the issue: Take any action which will lead to a change of the prefiltration prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program or change to water values due to steeper angulation. This will help to avoid the occurrence of this issue. Siemens Medical Solutions will contact customers to arrange a date to distribute a software update to permanently resolve the defect. |
| Quantity | 201 units in total |
| Distribution | Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221516 | ARTIS icono (Ceiling Configuration) Siemens Medical Solutions USA, Inc., Jul 19, 2022 |