Z-2242-2024Class II

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and...

Name: Z-2242-2024 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and...
Creator: Siemens AG/Siemens Healthcare GmbH
Published: 2024-06-26
License: https://open.fda.gov/license/

Siemens Healthineers AG / initiated 2024-06-26 / Open, Classified / root cause: software

FDA source

Siemens AG/Siemens Healthcare GmbH began a recall of ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited... on 2024-06-26. FDA classified it as Class II and gives the reason as "A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration...". 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-2242-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-26
Posted: 2024-07-02
Recalling firm: Siemens Healthineers AG
Product: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
Root cause tag: software
FDA root cause: Software design
Action: Inform customers of the temporary workaround to mitigate the issue: Take any action which will lead to a change of the prefiltration prior to the first x-ray release after a patient registration. This could be the first acquisition, the change of the organ program or change to water values due to steeper angulation. This will help to avoid the occurrence of this issue. Siemens Medical Solutions will contact customers to arrange a date to distribute a software update to permanently resolve the defect.
Quantity in commerce: 201 units in total
Distribution: Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.
Product codes and lots: ARTIS icono biplane 11327600 4056869063317 ARTIS icono ceiling 11328100 4056869295923 ARTIS icono floor 11327700 4056869149325

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2242-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2240-2024	Class II	Ongoing	FDA Mandated	2024-07-10	2024-07-02
Z-2241-2024	Class II	Ongoing	FDA Mandated	2024-07-10	2024-07-02
Z-2242-2024	Class II	Ongoing	FDA Mandated	2024-07-10	2024-07-02

Product code OWB

K230950Class IIARTIS icono (VE30A)Siemens Medical Solutions USA, Inc. / cleared 2023-12-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)