Z-2367-2019Class II

Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems...

Name: Z-2367-2019 Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems...
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-30 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis... on 2019-07-30. FDA classified it as Class II and gives the reason as "Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2367-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-30
Posted: 2019-08-24
Terminated: 2020-04-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281; Artis Q zeego 10848283 ArtisQ.zen ceiling 10848354 Product Usage: Artis is a family of dedicated angiography systems 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 family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. The Artis family can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (AX011/19/S) on 8/1/19 a . The letter identifies the reason for recall, health risk and action to take: Siemens Service organization will inspect the table mainframe for possible cracks and will contact you shortly to arrange a date to perform this corrective action. Contact the service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: US 17
Distribution: US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI
Product codes and lots: Serial Numbers: 123245 103302 121501 148401 109589 148393 111129 148400 103310 148397 155235 121505 109563 121506 131235 121502 105125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2367-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2367-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-24

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)