ARTIS Icono

• • Ongoing Z-1342-2022 FDA Class II ·initiated 20 May 2022 ·on shared 510(k) K193326

  During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

• 2 recalls, same reason

  • Ongoing Z-1245-2022 FDA Class II ·initiated 11 Apr 2022
  • Ongoing Z-1246-2022 FDA Class II ·initiated 11 Apr 2022

  if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

• 2 recalls, same reason

  • Ongoing Z-0985-2022 FDA Class II ·initiated 25 Feb 2022
  • Ongoing Z-0986-2022 FDA Class II ·initiated 25 Feb 2022

  Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed

• • 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.

• 2 recalls, same reason

  • Terminated Z-0516-2022 FDA Class II ·initiated 12 Oct 2021
  • Terminated Z-0517-2022 FDA Class II ·initiated 12 Oct 2021

  Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

• • Terminated Z-1497-2021 FDA Class II ·initiated 19 Mar 2021

  Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

• • Terminated Z-1288-2021 FDA Class II ·initiated 26 Feb 2021

  Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

• • Terminated Z-1144-2021 FDA Class II ·initiated 18 Dec 2020

  Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system

• • Terminated Z-0400-2021 FDA Class II ·initiated 18 Sep 2020

  There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.

• • Terminated Z-2257-2020 FDA Class II ·initiated 23 Apr 2020

  Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient

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

1. 26 Feb 2021 Recall initiated FDA recalls Z-1288-2021
2. 19 Mar 2021 Recall initiated FDA recalls Z-1497-2021
3. 12 Oct 2021 Recall initiated FDA recalls Z-0516-2022
4. 12 Oct 2021 Recall initiated FDA recalls Z-0517-2022
5. 25 Feb 2022 Recall initiated FDA recalls Z-0985-2022
6. 25 Feb 2022 Recall initiated FDA recalls Z-0986-2022
7. 25 Feb 2022 Recall initiated FDA recalls Z-1339-2022
8. 11 Apr 2022 Recall initiated FDA recalls Z-1245-2022
9. 11 Apr 2022 Recall initiated FDA recalls Z-1246-2022
10. 20 May 2022 Recall initiated FDA recalls Z-1342-2022

4 earlier events are in the sections above.

510(k) Number

K193326 ↗

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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