Z-1148-2018Class II

Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for...

Name: Z-1148-2018 Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-01-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-01-12 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures... on 2018-01-12. FDA classified it as Class II and gives the reason as "Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor". 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-1148-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-03-20
Terminated: 2018-08-28
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis one fluoroscopic x-ray system and patient table 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 Arts 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 i.e. patient extremities.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an Urgent - Medical Device Correction letter dated January 5, 2018. Siemens will conduct an inspection of all affected Artis tables and verify the correct positioning of the bolt as well as the snap rings. The letter recommends the consignees follow Please follow the standard emergency procedures they have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. The Siemens service organization will contact the consignees to arrange a date to perform the corrective action. For further questions, please call (610) 448-6461.
Quantity in commerce: 16
Distribution: US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.
Product codes and lots: Serial numbers: 82044 82105 82070 82213 82054 82040 82038 82205 82065 82267 82108 82010 82039 82109 82102 82066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1148-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1148-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21

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)