Z-2648-2026 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-2648-2026 was initiated by Siemens Medical Solutions USA, Inc on June 8, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 57 units.

Recall Details

Product Type
Devices
Report Date
July 8, 2026
Initiation Date
June 8, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
57 units

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.

Distribution Pattern

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

Code Information

Model Number: 11328100. UDI-DI: 4056869295923.