Z-0708-2018Class II

Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078...

Name: Z-0708-2018 Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-06-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-06-06 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392 on 2017-06-06. FDA classified it as Class II and gives the reason as "Potential for liquid entry". 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-0708-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Posted: 2018-02-23
Terminated: 2019-05-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential for liquid entry
Root cause tag: design
FDA root cause: Device Design
Action: On June 6, 2017, Siemens Healthineers distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via USPS Certified Mail. Siemens conducted a corrective field action in June 2015 to protect the Artis table against liquid entry at critical locations. However, even with this corrective action, if there are larger amounts of liquid on the table surface, they can still enter the table. Siemens Medical Solutions USA, Inc. will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment by calling 610-448-6461.
Distribution: U.S. Nationwide
Product codes and lots: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0706-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0707-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0708-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code OWB

K052202Class IIAxiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2006-03-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)