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Siemens AG/Siemens Healthcare GmbH recalls ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona
Recalled July 10, 2024 · FDA recall Z-2241-2024 · Siemens AG/Siemens Healthcare
Hazard
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 Class II
Units
201 units in total
Sold at
Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Description
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.
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.
Manufacturer(s)
Siemens AG/Siemens Healthcare GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →