Z-2344-2016Class II

Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137...

Name: Z-2344-2016 Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-07-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-07-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282... on 2016-07-07. FDA classified it as Class II and gives the reason as "Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup". 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-2344-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Posted: 2016-08-05
Terminated: 2016-12-13
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen 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 zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Important Customer Safety Notice dated July 7, 2016, by certified mail to customers to inform them of the corrective action they plan to take to prevent potential loss of the image display for live images in the examination room after system startup. Siemens service organization will contact each customer to arrange a date to resolve the issue with a software update of the monitor firmware via AX012/16/S. For questions regarding this recall call 610-448-6461.
Quantity in commerce: 51 units
Distribution: Nationwide Distribution to AL,AZ,CA,CO,IA,IL,MA,MD,MI,MN,MO,NE,NJ,NY,OH,OR,PA,RI,TX,VA,WA,WI,WV
Product codes and lots: Serial Numbers: 121185,147996,121169,105032,109190,109191,109197,109198,125100,158225,161021,154847,124083,123050,109187,124102,121167,125021,121163,117125,148001,158234,148010,158229,121171, 109183,109181,131101,158226,109194,117124,158244,109179,158238,109188,121179,137714,121168,158246,161022,121175,121173,154859,109186,158230,123046,158227,109189,123052,105029,105030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2344-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2344-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05

Product code IZI

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)