Class 2 Device Recall ARTIS Icono (Ceiling Configuration)

• Date Initiated by Firm: June 26, 2024
• Date Posted: July 02, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2241-2024
• Recall Event ID: 94892
• 510(K)Number: K221516
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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.
• Code Information: ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325
• FEI Number: 3004977335
• Recalling Firm/ Manufacturer: Siemens AG/Siemens Healthcare GmbH; Rittigfeld 1; Forchheim Germany
• For Additional Information Contact: 499191-180
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB