Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0656-2021

November 30, 2020

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 87026
Status
Ongoing
Classification
Class II
Quantity
5602
Official record key
device-enforcement:Z-0656-2021

Official wording

Reason: 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.

Code information: Model 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

Distribution pattern: Worldwide-US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.