Recall StatusOpen, Classified
Date Initiated2024-06-26
Product Quantity201 units in total
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.