Z-0956-2023Class II

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Name: Z-0956-2023 ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-12-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-12-16 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor on 2022-12-16. FDA classified it as Class II and gives the reason as "Mechanical connection between the tabletop and table base may be lost". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0956-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-16
Posted: 2023-01-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Mechanical connection between the tabletop and table base may be lost.
Root cause tag: design
FDA root cause: Device Design
Action: A customer letter dated 12/16/2022 was issued to affected consignees. Consignees are advised the following: -Before treatment is started, check if both transversal guide rails and the roller bearing at the end of each rail are in the correct position. -For the affected OR tables, an inspection including installation of a safety measure will be carried out. Siemens is currently developing this mitigation. Once correction is available, the service department will contact the consignees to arrange a date to perform the corrective action. Consignees are requested to acknowledge the recall letter and return the acknowledgement form to Siemens promptly.
Quantity in commerce: 550 units
Distribution: Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kuwait, Lebanon, Monaco, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: 1) ARTIS pheno; Material #10849000; UDI/DI: 4056869046877 2) ARTIS icono biplane; Material #11327600; UDI/DI: 4056869063317 3) ARTIS icono floor; Material #11327700; UDI/DI: 4056869149325

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0956-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0956-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-13

Product code OWB

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)