Recall Z-2648-2026— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2648-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-08

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2026-06-08. It names one FDA 510(k) clearance: K221516. Product: ARTIS icono ceiling. Model Number: 11328100.. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-06-08
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K221516 — ARTIS icono (Ceiling Configuration)Siemens Medical Solutions USA, Inc.·cleared 2022-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ARTIS icono ceiling. Model Number: 11328100.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.