# K181407: Artis zee/zeego & Artis Q/Q.zen

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solution USA, Inc.
- Decided: Aug 15, 2018 after 77 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 59 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 45 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141574: Artis Zee/Zeego SW VC21, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K123529: Artis Q and Q.Zen- Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.

## Most influential descendants
- K190768: ARTIS icono (2019), 10 descendants of its own
- K201156: ARTIS pheno (VE2) (2020), 5 descendants of its own
- K220432: ARTIS icono (VE21) System (2022), 4 descendants of its own
- K220409: ARTIS pheno (VE21) System (2022), 4 descendants of its own
- K230949: ARTIS pheno (VE30A) (2023), 3 descendants of its own

## Recalls of this device
- Mar 21, 2024 · Class II · Z-1598-2024: Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE H
- Dec 16, 2022 · Class II · Z-1040-2023: In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment o
- Aug 10, 2022 · Class II · Z-1645-2022: Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanis
- May 24, 2022 · Class II · Z-1343-2022: It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all st
- Feb 23, 2022 · Class II · Z-0972-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0971-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0976-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0979-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0968-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0975-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0969-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0970-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0974-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0973-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0980-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0967-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0977-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Feb 23, 2022 · Class II · Z-0978-2022: If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message
- Oct 20, 2021 · Class II · Z-0305-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0299-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0296-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0297-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0302-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0300-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0301-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0303-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0298-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Oct 20, 2021 · Class II · Z-0304-2022: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d
- Sep 24, 2021 · Class II · Z-0200-2022: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstr
- Jun 30, 2021 · Class II · Z-2404-2021: Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
- Mar 30, 2021 · Class II · Z-1496-2021: Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the be
- Mar 26, 2021 · Class II · Z-1495-2021: Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. 
- Nov 30, 2020 · Class II · Z-0656-2021: When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the
- Oct 21, 2020 · Class II · Z-0469-2021: Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properl
- Aug 3, 2020 · Class II · Z-0108-2021: Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls
- Apr 30, 2020 · Class II · Z-2302-2020: Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result i
- Feb 14, 2020 · Class II · Z-1495-2020: A software issue could potentially cause the stand and table movements to be blocked.
- Feb 14, 2020 · Class II · Z-1496-2020: A software issue could potentially cause the stand and table movements to be blocked.
- Feb 14, 2020 · Class II · Z-1497-2020: A software issue could potentially cause the stand and table movements to be blocked.
- Nov 14, 2019 · Class II · Z-0695-2020: In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or inte
- Jul 30, 2019 · Class II · Z-2367-2019: Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patient
- Jun 12, 2019 · Class II · Z-2033-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2030-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2034-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2029-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2028-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2031-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2032-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 6, 2019 · Class II · Z-1903-2019: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to th
- Jun 6, 2019 · Class II · Z-1896-2019: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to th

## Indications for use
Artis 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 family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. Artis can also support the acquisition of position triggered imaging for spatial data synthesis. The Artis systems include also the software option DynaCT with following IFU: DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K181407
Methodology: https://510kreport.com/methodology