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.

GE Medical Systems, SCS Medical Device Recall: Senographe Pristina | SafeCheck