# K073290: Artis Zee and Zeego

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 11, 2008 after 82 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801623 (1980). 40 ancestors in all.
72 later devices descend from it; 3 cite it directly.
4 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021021: Modular Angiography System Axiom Artis, Siemens Medical Solutions USA, Inc. (2002)
- K052202: Axiom Artis - Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2006) Summary page 2.

## Most influential descendants
- K090745: Artis Zee / Zeegos with SW VC14 (2009), 69 descendants of its own
- K123529: Artis Q and Q.Zen- Modular Angiographic System (2013), 33 descendants of its own
- K122644: Artis Zee/Zeego with CSX-10 Detector SW VC21 (2013), 30 descendants of its own
- K102005: Allura Xper or Table Series (2010), 24 descendants of its own
- K163286: ARTIS pheno (2017), 23 descendants of its own

## Recalls of this device
- Apr 9, 2019 · Class II · Z-1339-2019: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
- Apr 9, 2019 · Class II · Z-1340-2019: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
- Oct 26, 2018 · Class II · Z-0558-2019: This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit 
- Oct 19, 2018 · Class II · Z-0457-2019: Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
- Sep 28, 2017 · Class II · Z-0710-2018: The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no lo
- Aug 24, 2017 · Class II · Z-0508-2018: Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standa
- Jun 6, 2017 · Class II · Z-0707-2018: Potential for liquid entry
- Mar 28, 2017 · Class II · Z-1824-2017: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the 
- Feb 27, 2017 · Class II · Z-1467-2017: A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare ca
- Feb 3, 2017 · Class II · Z-2686-2017: Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
- Jul 13, 2016 · Class II · Z-2394-2016: The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
- Jul 7, 2016 · Class II · Z-2344-2016: 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.
- Feb 26, 2016 · Class II · Z-1299-2016: 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 generato
- Feb 19, 2016 · Class II · Z-1311-2016: Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
- Feb 18, 2016 · Class II · Z-1284-2016: Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur
- Feb 18, 2016 · Class II · Z-3093-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3095-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3099-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3094-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3096-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3092-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3097-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3098-2017: 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 occu
- Oct 30, 2015 · Class II · Z-0481-2016: Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the 
- Jun 29, 2015 · Class II · Z-2340-2015: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible.
- Sep 23, 2014 · Class II · Z-0183-2015: 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 exist
- Sep 17, 2014 · Class II · Z-0854-2015: 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 restricti
- Jun 5, 2014 · Class II · Z-2587-2014: There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
- Jun 5, 2014 · Class II · Z-2569-2014: There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the releas
- Feb 7, 2014 · Class II · Z-1272-2014: Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry syste
- Feb 7, 2014 · Class II · Z-1309-2014: An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
- Dec 16, 2013 · Class II · Z-1080-2014: During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
- Sep 11, 2013 · Class II · Z-0486-2015: There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the to
- Jun 26, 2013 · Class II · Z-1782-2013: Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. 
- Mar 8, 2013 · Class II · Z-0997-2013: The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ p
- Jul 13, 2010 · Not classified · Z-2233-2010: The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in 
- Oct 26, 2009 · Not classified · Z-0485-2010: c-arm may tilt
- May 1, 2009 · Not classified · Z-1443-2009: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
- Aug 22, 2008 · Not classified · Z-0194-2009: Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table.

## Indications for use
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. Procedures that can be performed with the Artis zee / zeego family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.

Source page: https://510kreport.com/device/K073290
Methodology: https://510kreport.com/methodology