Z-0656-2021Class II

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

Name: Z-0656-2021 Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-11-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-11-30 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno on 2020-11-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0656-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-30
Posted: 2021-01-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 5602
Distribution: Worldwide-US Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0656-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2021	Class II	Ongoing	FDA Mandated	2021-01-20	2021-01-11

Product code OWB

K181407Class IIArtis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. / cleared 2018-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)