Z-1899-2019Class II

Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

Name: Z-1899-2019 Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
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 Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281 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-1899-2019
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 Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
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: 131
Distribution: Nationwide
Product codes and lots: Serial Numbers: 109007 109057 109028 109027 109011 109021 109009 109010 109072 109075 109071 109041 109039 109032 109020 109036 109048 109088 109101 109040 109034 109031 109043 109067 109068 109093 109080 109179 109134 109133 109496 109076 109105 109104 109107 109084 109060 109164 109167 109135 109119 109090 109096 109091 109146 109102 109092 109189 109129 109143 109183 109606 109144 109171 109155 109217 109159 109172 109211 109169 109229 109166 109388 109350 109332 109210 109309 109203 109369 109300 109202 109401 109302 109346 109429 109214 109301 109311 109320 109330 109349 109373 109361 109231 109379 109331 109432 109434 109324 109417 109327 109344 109367 109435 109352 109380 109515 109461 109386 109365 109415 109366 109412 109383 109493 109518 109445 109437 109558 109526 109458 109424 109456 109451 109463 109467 109598 109484 109536 109538 109500 109501 109592 109527 109569 109627 109599 109591 109613 109610 109628

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1899-2019
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)