GE Medical Systems, LLC device recall (Cls II)

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography — Reason: 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). — Status: Ongoing