Z-0854-2015Class II

Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated...

Name: Z-0854-2015 Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-09-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-09-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane... on 2014-09-17. FDA classified it as Class II and gives the reason as "The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual...". 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-0854-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-17
Posted: 2015-01-14
Terminated: 2015-08-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Planned action (s) to repair defect or to bring product into compliance for Siemens Medical Solutions Inc. concerning the corrective action plan (CAP) for the Model(s) Artis Zee/Zeego Stationary Angiographic X-ray Systems. 1.Notifying the customer of the defect. 2.Implementing a corrective software patch to protect the system from damage in the event of hardware failure 3. Scheduling a service visit from a Siemens representative to perform a hardware replacement. 4. Replacing the non-conforming X-ray tube with one manufactured after the nonconformity issue was resolved. For further questions please call (610) 219-6300.
Quantity in commerce: 44
Distribution: USA Distribution to the states of MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.
Product codes and lots: model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, with serial numbers: 160348 146643 147129 146630 147208 146972 153707 147378 146742 157650 146986 147098 157696 153946 146940 147144 147029 160384 153884 147009 153628 153706 146729 147155 153790 146896 153757 136503 147372 136345 153762 146883 160421 153195 146427 153834 135927 154157 135862 153998 153257 153220 153682 160341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0854-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0854-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

Product code IZI

K073290Class IIArtis Zee and ZeegoSiemens Medical Solutions USA, Inc. / cleared 2008-02-11

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)