Z-2748-2018Class II

ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System

Name: Z-2748-2018 ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-06-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-06-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and... on 2018-06-22. FDA classified it as Class II and gives the reason as "Potential hardware issue which may cause thermal effects and possible damage to system parts". 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-2748-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-22
Posted: 2018-08-11
Terminated: 2020-01-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: 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 Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. 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 hardware issue which may cause thermal effects and possible damage to system parts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 22, 2018, Siemens Healthineers issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. In the event the problem occurs, the system can be operated normally, however, in the case of a leakage current, X-ray will not be possible. This may result in a situation where it is necessary to cancel or restart clinical treatment or to continue treatment on an alternative system. 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 error by updating all affected generators with a RCD (Residual Current Device) to detect leakage currents via Update Instruction AX060/16/S. Additionally, Siemens recommends installing a RCD (Residual Current Device) in the electrical system of the hospital as an appropriate backup system and general electrical protection. You may continue to use the Artis Q and Artis Pheno systems while awaiting implementation of the corrective action. Siemens Healthineers will contact customers to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: 605 units in total
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: 164033 164071 164034 164095 164057 164054 164055 164080 164072 164088 164048 164094 164068 164019 164013 164073 164025 164026 164027 164060 164083 164113 164021 164066 164075 164074 164084 164086 164098 164028 164053 164063 164064 164105 164024 164049 164018 164022 164061 164115 164100 164097 164011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2748-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2747-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10
Z-2748-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10

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