Reported Jul 10, 2024 · Ongoing
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Siemens AG/Siemens Healthcare GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens AG/Siemens Healthcare GmbH · Rittigfeld 1 · Forchheim, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 113276004056869063317ARTIS icono ceiling 113281004056869295923ARTIS icono floor 113277004056869149325— - Amount recalled
- 201 units in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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