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Siemens Medical Solutions USA, Inc Recall 87026

Description: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

Siemens Medical Solutions USA, Inc Recall 87026 Information

Mandated?FDA Mandated
Recall NumberZ-0656-2021
Event ID87026
Event DescriptionArtis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Product TypeDevices
DistributionWorldwide-US Nationwide
Recall ReasonWhen 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.
Device Classification20210120
Device Code InfoModel number: Artis 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
Center Classification Date20210111
Recall Initiation Date20201130
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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