Z-0458-2019Class II

ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system

Name: Z-0458-2019 ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-10-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-10-19 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and... on 2018-10-19. FDA classified it as Class II and gives the reason as "Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support". 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-0458-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-19
Posted: 2018-11-14
Terminated: 2020-04-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken. Siemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S.
Quantity in commerce: 54 units
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: 121336 121368 121208 121371 121374 121209 121325 121357 121378 121369 121364 121314 121351 121354 121340 121365 121324 121216 121333 121381 121352 121355 121210 121215 121379 121366 121323 121370 121384 121332 121344 121309 121305 121342 121301 121315 121372 121321 121383 121312 121359 121322 121356 121319 121211 121375 121377 121361 121339 121310 121362 121316 121212 121313

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0458-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0457-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13
Z-0458-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13
Z-0459-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-13

Product code OWB

K123529Class IIArtis Q and Q.zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2013-02-26

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)