ARTIS pheno (VE2)

• • Ongoing Z-1294-2022 FDA Class II ·initiated 10 Jun 2022 ·on shared 510(k) K201156

  A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

• • Ongoing Z-0987-2022 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.

• • 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-0515-2022 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.

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

1. 29 Jun 2020 Cleared FDA 510(k) K201156
2. 19 Mar 2021 Recall initiated FDA recalls Z-1497-2021
3. 27 May 2021 Recall initiated FDA recalls Z-2029-2021
4. 12 Oct 2021 Recall initiated FDA recalls Z-0515-2022
5. 25 Feb 2022 Recall initiated FDA recalls Z-0987-2022
6. 25 Feb 2022 Recall initiated FDA recalls Z-1339-2022
7. 10 Jun 2022 Recall initiated FDA recalls Z-1294-2022

510(k) Number

K201156 ↗

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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