Z-0922-2025Class II

ARTIS One Angiographic X-Ray System

Name: Z-0922-2025 ARTIS One Angiographic X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-01-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-01-02 / Open, Classified

FDA source

SIEMENS MEDICAL SOLUTIONS USA, INC began a recall of ARTIS One Angiographic X-Ray System on 2025-01-02. FDA classified it as Class II and gives the reason as "A potential issue with ARTIS One systems 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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0922-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-02
Posted: 2025-01-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS One Angiographic X-Ray System
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A potential issue with ARTIS One systems 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.
FDA root cause: Radiation Control for Health and Safety Act
Quantity in commerce: 1140
Distribution: 23 Distributed in the US
Product codes and lots: Model Number 10848600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0922-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0922-2025	Class II	Ongoing		2025-02-05	2025-01-28

Product code OWB

K133580Class IIArtis OneSiemens Medical Solutions USA, Inc. / cleared 2014-04-28

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)