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Siemens Medical Solutions USA, Inc recalls Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Recalled January 20, 2021 · FDA recall Z-0656-2021 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
5602
Sold at
Worldwide-US Nationwide
Description
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.
Product
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →