Class II

Medical Device Recall: Senographe Pristina

GE Medical Systems, SCS · December 26, 2023

Reason for Recall

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

Distribution

Us Nationwide-Worldwide Distribution

States Affected

NATIONWIDE

Quantity Affected

180 units (60 US; 120 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0862-2024

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.