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.
This recall is currently active, issued July 2, 2024. It was issued by Siemens Ag/Siemens Healthcare Gmbh Rittigfeld 1 Forchheim Germany.
- Recall Initiated
- June 26, 2024
- Posted
- July 2, 2024
- Recall Number
- Z-2240-2024
- Quantity
- 201 units in total
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Lot / Code Info
ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325
Root Cause
Software design
Action Taken
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.