Siemens Medical Solutions USA, Inc ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
Products Sold
UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
Siemens Medical Solutions USA, Inc is recalling ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100 due to Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Recommended Action
Per FDA guidance
On October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mitigate the probability of occurrence of the issue. You may contact the firm's service organization for an earlier appointment at 1-800-888-7436.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026