FDA Medical Device · Z-2648-2026

ARTIS icono ceiling. Model Number: 11328100.

Class II · Ongoing

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.

Advertisement
Advertisement
Affected lots / codes — check yours against thisModel Number: 11328100. UDI-DI: 4056869295923.
Recalling firm
Siemens Medical Solutions USA, Inc, Malvern, PA
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
57 units
Distribution
US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Recall initiated
June 8, 2026
Classified
July 1, 2026
Initiation
Voluntary: Firm initiated
Advertisement
Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2648-2026%22
Advertisement
Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →