Z-0614-2018Class II

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system...

Name: Z-0614-2018 Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system...
Creator: Siemens Medical Solutions USA, INC
Published: 2017-08-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-08-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, INC began a recall of Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for... on 2017-08-22. FDA classified it as Class II and gives the reason as "The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen". 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-0614-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-22
Posted: 2018-02-14
Terminated: 2018-08-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis oneFloor-mounted system for uncompromised imaging; 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. X-ray generator POLYDOROS A100 Plus
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent- Medical Device Correction letter dated August 22, 2017. Our service organization will contact you shortly to arrange a date to perform this corrective action (A system hardware update will be implemented and all affected DP Transceivers below revision 03 will be updated). Following the system hardware update, the cause is eliminated and a recurrence of the fault is prevented. For further questions, please call (610) 448-6461.
Quantity in commerce: 207 worldwide (13 distributed in US)
Distribution: US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.
Product codes and lots: Serial # 82044; 82105; 82070; 82054; 82040;82038;82065 82108; 82010; 82039; 82109 82102 82066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0614-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0614-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-14

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)