Z-1897-2019Class II

Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

Name: Z-1897-2019 Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-06-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-06-06 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959 on 2019-06-06. FDA classified it as Class II and gives the reason as "Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted...". 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-1897-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-06
Posted: 2019-06-28
Terminated: 2021-02-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.
Quantity in commerce: 29
Distribution: Nationwide
Product codes and lots: Serial Numbers: 160335 160430 160368 160469 160357 160370 160369 160509 160427 160433 160443 160428 160429 160463 160001 160461 160486 160800 160487 160488 160507 160840 160862 160856 160823 160914 160930 161235 160401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1897-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1894-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1895-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1896-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1897-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1898-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1899-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1900-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1901-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1902-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1903-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1904-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28
Z-1905-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-06-28

Product code OWB

K181407Class IIArtis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. / cleared 2018-08-15

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)