FDA recall Z-0875-2026

GE Medical Systems, LLC · Class II · device

Product

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Reason for recall

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

Distribution

U.S. and OUS.

Key facts

Status: Ongoing
Initiation date: 2025-10-24
Report date: 2025-12-17
Voluntary/Mandated: FDA Mandated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2026