Z-1343-2022Class II

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray...

Name: Z-1343-2022 Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-05-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-05-24 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System on 2022-05-24. FDA classified it as Class II and gives the reason as "It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1343-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-24
Posted: 2022-07-07
Terminated: 2025-01-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.
Root cause tag: design
FDA root cause: Component design/selection
Action: On May 24, 2022, the firm mailed Urgent Medical Device Correction letters to affected consignees. Customers were informed that if the system is not used regularly, please ensure that the system is switched on in due time before any use to check the status. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. The firm will replace the Bios battery and the service interval will be shortened to two years. The firm will contact customers to arrange a date to perform the correction. Customers may call the service organization at 1-800-888-7435 to schedule an earlier appointment.
Quantity in commerce: 233 worldwide; 32 US
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, FL, IL, LA, ME, MN, MO, NC, OH, PA, SC, TN, TX, WI and the countries of Australia, Austria, Azerbaijan, Belgium, Canada, China, Finland, France, Germany, Hong Kong, India, Italy, Japan, Lebanon, Lithuania, Luxembourg, Netherlands, Poland, Portugal, South Korea, Switzerland, United Kingdom.
Product codes and lots: UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1343-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1343-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-07

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)