Recall Z-2648-2026

Siemens Medical Solutions USA, Inc · initiated June 8, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

ARTIS icono ceiling. Model Number: 11328100.

Codes / lots: Model Number: 11328100. UDI-DI: 4056869295923.

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.

FDA-determined cause: Device Design

Action taken

Siemens Healthineers notified consignees on about 06/08/2026 via "CUSTOMER SAFETY ADVISORY NOTICE" letter. Consignees were instructed to conduct regular inspections of the gap between the monitor carrier and the ceiling-mounted arm and be attentive to any unusual noises, shaking, wobbling, or other unexpected behavior during system operation, as these may indicate loose screws. If any such signs are observed, limit movements of the DCS and contact Siemens service organization immediately for further instructions. Always ensure that the DCS is positioned for safe use. All affected systems will be corrected by Siemens Healthineers service engineers. Siemens engineers will correct the screwed connection of the monitor ceiling support according to the adapted specifications and instructions. The correction will be released via an Update Instruction AX022/26/S. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.

Details

Recall number
Z-2648-2026
Initiated
June 8, 2026
Posted by FDA
July 1, 2026
Product code
OWB – Interventional Fluoroscopic X-Ray System
Quantity
57 units
Distribution
US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Recalling firm
Siemens Medical Solutions USA, Inc, Malvern, PA

Official FDA recall record