Z-0183-2015Class II

Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated...

Name: Z-0183-2015 Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated...
Creator: Siemens Medical Solutions USA, Inc
Published: 2014-09-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2014-09-23 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane... on 2014-09-23. FDA classified it as Class II and gives the reason as "A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable...". 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-0183-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-23
Posted: 2014-11-07
Terminated: 2017-05-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system 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: A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens sent an " Important Safety Information " letter dated September 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Siemens will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Our service organization will contact with you to schedule an appointment to perform the corrective action. Please feel free to contact our service organization for an earlier appointment. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 219-6300.
Quantity in commerce: 164
Distribution: Nationwide Distribution including Puerto Rico.
Product codes and lots: model number 10280959, with serial numbers 1000-1599

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

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)