Senographe Pristina
FDA Recall #Z-0862-2024 — Class II — December 26, 2023
Product Description
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.
Recalling Firm
GE Medical Systems, SCS — Buc
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
180 units (60 US; 120 OUS)
Distribution
Us Nationwide-Worldwide Distribution
Code Information
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Status
Ongoing
Voluntary / Mandated
FDA Mandated