Z-1340-2020Class II

ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 -

Name: Z-1340-2020 ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-01-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-01-24 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed... on 2020-01-24. FDA classified it as Class II and gives the reason as "Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1340-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-24
Posted: 2020-02-20
Terminated: 2020-07-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued Urgent Medical Device Correction letter dated January 24, 2020 A via AX064/19/S ( corrective action via AX063/19/S), stating reason for recall, health risk and a corrective action: In the event the robotic stand shows stuttering movements or a squealing noise while initiating movements, do not move the robotic stand and C-arm any longer. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will correct the hardware error by replacing all affected relays and altering the wiring via Update Instruction AX063/19/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented
Quantity in commerce: 96 US
Distribution: US Nationwide distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1340-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1340-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-20

Product code OWB

K163286Class IIARTIS phenoSiemens Medical Solution USA, Inc. / cleared 2017-03-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)