Z-0807-2020Class II

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System -

Name: Z-0807-2020 Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System -
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-12-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-12-20 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging... on 2019-12-20. FDA classified it as Class II and gives the reason as "The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred". 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-0807-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-20
Posted: 2020-01-13
Terminated: 2020-05-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019.
Quantity in commerce: 6
Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Product codes and lots: Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0807-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0807-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13

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)