Siemens Medical Solutions USA, Inc Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Siemens Medical Solutions USA, Inc is recalling Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno due to 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 Ove. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers via AX067/20/P on November 30, 2020. All modifications and repairs are provided to affected customers free of charge.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026