Z-2012-2019Class II

AXIOM Artis FC, Model Number 5904433

Name: Z-2012-2019 AXIOM Artis FC, Model Number 5904433
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-06-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-06-12 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis FC, Model Number 5904433 on 2019-06-12. FDA classified it as Class II and gives the reason as "A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be...". 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-2012-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-12
Posted: 2019-07-22
Terminated: 2020-09-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis FC, Model Number 5904433
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Root cause tag: design
FDA root cause: Component design/selection
Action: Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated and any recurrence of this potential fault is prevented.
Quantity in commerce: 5
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: 10436 10444 10425 10433 10435

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2012-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2012-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2013-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2014-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2015-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2016-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2017-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2018-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2019-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2020-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2021-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2022-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2023-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2024-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2025-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2026-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2027-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2028-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2029-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2030-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2031-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2032-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2033-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22
Z-2034-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22

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