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Open, Classified

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.

FDA Recall Z-2241-2024 · Posted 2024-07-02

Recall StatusOpen, Classified
Product CodeOWB
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.

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