FDA recall Z-0862-2024

GE Medical Systems, SCS · Class II · device

Product

Senographe Pristina

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

Key facts

Status: Ongoing
Initiation date: 2023-12-26
Report date: 2024-02-14
Voluntary/Mandated: FDA Mandated
Location: Buc, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0862-2024