ARTIS Angiography System (Siemens) – Detector Potential Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Siemens AG/Siemens Healthcare GmbH Rittigfeld 1 Forchheim Germany
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325
Siemens AG/Siemens Healthcare GmbH Rittigfeld 1 Forchheim Germany is recalling ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imagi due to A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very ra. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026