Z-1282-2016Class II

Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for...

Name: Z-1282-2016 Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-03-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-03-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures... on 2016-03-11. FDA classified it as Class II and gives the reason as "After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1282-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-11
Posted: 2016-03-31
Terminated: 2017-11-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Siemens mailed an Important Customer Safety Notice to customers to inform them of the issue and the corrective actions they plan to take to address the problem. The letter stated that Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers were instructed to call Siemens service organization for an appointment at 1-800-888-7436.
Quantity in commerce: 1 angiography system
Distribution: Nationwide Distribution to Michigan only
Product codes and lots: Serial # 82010, material # 10848600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1282-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1282-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

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