Class II
Medical Device Recall: interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc · May 15, 2025
Reason for Recall
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Distribution
Worldwide.
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2021-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.