Z-1119-2015Class II

Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures...

Name: Z-1119-2015 Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-01-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-01-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese... on 2015-01-16. FDA classified it as Class II and gives the reason as "The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1119-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-16
Posted: 2015-02-17
Terminated: 2015-04-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis One; The Artis One is an angiography system developed for diagnostic 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. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens notified their customer via Customer Safety Advisory Letter AX049/14/S, dated January 16, 2015, and has initiated a fix with Update Instruction AX048/14/S which will be completed by a Siemens service technician. Customers with questions should contact the Customer Care Center at 1-800-888-7436. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 1
Distribution: Nationwide Distribution to MI only
Product codes and lots: Model Number 10848600, serial number 82010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1119-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-17

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)