Z-3190-2018Class II

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

Name: Z-3190-2018 ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-07-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-07-29 / 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 on 2018-07-29. FDA classified it as Class II and gives the reason as "Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for...". 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-3190-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-29
Posted: 2018-09-18
Terminated: 2019-05-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Correction notification letters dated 7/27/18 were distributed to customers. The letters informed the customers of the following planned actions: Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX001/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.
Quantity in commerce: 429 total
Distribution: US nationwide distribution.
Product codes and lots: 164013 164011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3190-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3189-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18
Z-3190-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

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)