Medical Device Recall: 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.
Siemens AG/Siemens Healthcare GmbH · June 26, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
201 units in total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2241-2024
Status: ongoing
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