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Recall Observatory FDA recall evidence

Device product

ARTIS icono ceiling. Model Number: 11328100.

Z-2648-2026

June 08, 2026

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 99224
Status
Ongoing
Classification
Class II
Quantity
57 units
Official record key
device-enforcement:Z-2648-2026

Official wording

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.

Code information: Model Number: 11328100. UDI-DI: 4056869295923.

Distribution pattern: US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.