Skip to content

ARTIS icono (Ceiling Configuration)

by Siemens Medical Solutions USA, Inc.

510(k) K221516

ARTIS icono (Ceiling Configuration) is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K221516 on 19 Jul 2022, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK221516 Date19 Jul 2022ClearedStatusActive

Official records

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2648-2026 FDA Class II initiated 8 Jun 2026

    Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

    • Ongoing Z-2241-2024 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.

    • Ongoing Z-0523-2024 FDA Class II initiated 17 Oct 2023

    Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.

Timeline

4 dated events

  1. Cleared FDA 510(k) K221516
  2. Recall initiated FDA recalls Z-0523-2024
  3. Recall initiated FDA recalls Z-2241-2024
  4. Recall initiated FDA recalls Z-2648-2026

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  • Withdrawn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

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →