Z-1299-2016Class II

system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a...

Name: Z-1299-2016 system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-26 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed... on 2016-02-26. FDA classified it as Class II and gives the reason as "In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to...". 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-1299-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-26
Posted: 2016-03-31
Terminated: 2017-06-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego 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.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Siemens, sent an "Important Customer Safety Notice" dated 2/16/2016 to its customers. The notice informed them of a corrective action that will be performed to prevent a possible hazard to patients, operators, other persons or equipment. The notice described the product, problem and actions to be taken. Siemens plans to contact each customer to arrange a date to add additional protection mechanisms by means of a system software update. If you have any questions, contact Engineer, Regulatory Technical Specialist at 610-448-6461 or email: [email protected].
Quantity in commerce: 552 units
Distribution: US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.
Product codes and lots: Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1299-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1299-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

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)