Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARTIS is a family of dedicated angiography systems developed for Recalled by Siemens AG/Siemens Healthcare GmbH Due to A potential issue with ARTIS icono systems equipped...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens AG/Siemens Healthcare GmbH directly.
Affected Products
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.
Quantity: 201 units in total
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens AG/Siemens Healthcare GmbH
Siemens AG/Siemens Healthcare GmbH has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report