Reported Jan 20, 2021 · Ongoing
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Siemens Medical Solutions USA, Inc.
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 Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
- Lot codes and dates
- Model numberArtis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Pheno- 10849000 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355
- Amount recalled
- 5602
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
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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