ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures incl...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2242-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2242-2024.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2242-2024.
Siemens AG/Siemens Healthcare GmbH
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Siemens Ag/siemens Healthcare Gmbh Recall FAQ
Siemens Ag/siemens Healthcare Gmbh is the subject of a diagnostic devices safety report: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures incl.... The notice was published on June 26, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 201 units are potentially affected.