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ARTIS icono (VE21) System

by Siemens Medical Solutions USA, Inc.

510(k) K220432

ARTIS icono (VE21) System is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K220432 on 29 Jun 2022, active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220432 Date29 Jun 2022ClearedStatusActive

Official records

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-2240-2024 FDA Class II initiated 26 Jun 2024

    A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

  • 2 recalls, same reason

    • Ongoing Z-2359-2023 FDA Class II initiated 19 Jun 2023
    • Ongoing Z-2360-2023 FDA Class II initiated 19 Jun 2023

    Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

    • Ongoing Z-1647-2022 FDA Class II initiated 10 Aug 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 mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

Timeline

5 dated events

  1. Cleared FDA 510(k) K220432
  2. Recall initiated FDA recalls Z-1647-2022
  3. Recall initiated FDA recalls Z-2359-2023
  4. Recall initiated FDA recalls Z-2360-2023
  5. Recall initiated FDA recalls Z-2240-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWB
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

Cited by

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

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