ARTIS pheno

• • Ongoing Z-1498-2023 FDA Class II ·initiated 2 Feb 2023

  If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.

• • Ongoing Z-1311-2023 FDA Class II ·initiated 2 Feb 2023

  In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

• • Ongoing Z-0956-2023 FDA Class II ·initiated 16 Dec 2022

  Mechanical connection between the tabletop and table base may be lost.

• • Ongoing Z-0119-2023 FDA Class II ·initiated 20 Sep 2022 ·on shared 510(k) K163286

  Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

• • Ongoing Z-1339-2022 FDA Class II ·initiated 25 Feb 2022

  After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

• • Ongoing Z-2029-2021 FDA Class II ·initiated 27 May 2021

  Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

• • Terminated Z-2108-2020 FDA Class II ·initiated 22 Apr 2020

  If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer

• • Terminated Z-1340-2020 FDA Class II ·initiated 24 Jan 2020

  Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

• • Terminated Z-0807-2020 FDA Class II ·initiated 20 Dec 2019

  The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

• • Terminated Z-1905-2019 FDA Class II ·initiated 6 Jun 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 the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

• • Terminated Z-3190-2018 FDA Class II ·initiated 29 Jul 2018

  Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

• • Terminated Z-2748-2018 FDA Class II ·initiated 22 Jun 2018

  Potential hardware issue which may cause thermal effects and possible damage to system parts.

• • Terminated Z-2524-2018 FDA Class II ·initiated 30 May 2018

  During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

• • Terminated Z-2283-2018 FDA Class II ·initiated 1 May 2018

  If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 6 Jun 2019 Recall initiated FDA recalls Z-1905-2019
2. 20 Dec 2019 Recall initiated FDA recalls Z-0807-2020
3. 24 Jan 2020 Recall initiated FDA recalls Z-1340-2020
4. 22 Apr 2020 Recall initiated FDA recalls Z-2108-2020
5. 27 May 2021 Recall initiated FDA recalls Z-2029-2021
6. 25 Feb 2022 Recall initiated FDA recalls Z-1339-2022
7. 20 Sep 2022 Recall initiated FDA recalls Z-0119-2023
8. 16 Dec 2022 Recall initiated FDA recalls Z-0956-2023
9. 2 Feb 2023 Recall initiated FDA recalls Z-1498-2023
10. 2 Feb 2023 Recall initiated FDA recalls Z-1311-2023

5 earlier events are in the sections above.

510(k) Number

K163286 ↗

FDA product code

OWB

Device class

Class II

Regulation

21 CFR Part 892.1650

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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