GE Medical Systems, SCS recalls Senographe Pristina

Recalled February 14, 2024 · FDA recall Z-0862-2024 · GE Medical Systems, SCS

Hazard

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

Units

180 units (60 US; 120 OUS)

Sold at

Us Nationwide-Worldwide Distribution

Description

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

Product

Senographe Pristina

Manufacturer(s)

GE Medical Systems, SCS

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →