Z-3097-2017Class II

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of...

Name: Z-3097-2017 Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-18 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and... on 2016-02-18. FDA classified it as Class II and gives the reason as "Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3097-2017
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2017-08-29
Terminated: 2017-11-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee 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 AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM 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 a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 18, 2016, to affected customers informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an appointment to schedule the work For questions regarding this recall call 610-.448-6461.
Quantity in commerce: 986 units in USA
Distribution: Nationwide Distribution
Product codes and lots: Artis zee multi-purpose - Serial number: 157660 158170 130017 157698 158108 157657 157988 157690 158091 157616 157710 158132 157677 157615 157700 157977 157602 158183 157642 158121 157975 157969 157579 157573 157650 157671 157713 158080 130013 157928 157696 157989 157644 157648 157999 158066 158180 158032 158134 130019 157601 157992 157625 158079 157600 157604 157634 157635 158081 158104 158105 158056 157965 157570 157658 157594 158027 157706 158042 157674 157907 158043 157668 158019 157692 157936 157984 158113 157707 157708 157661 157688 158136 157987 158028 157702 158191 158138 158126 157704 158186 157667 158133 157645

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3097-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3088-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3089-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3090-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3091-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3092-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3093-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3094-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3095-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3096-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3097-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3098-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29
Z-3099-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-29

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)