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Open, Classified

Senographe Pristina

FDA Recall Z-0862-2024 · Posted 2024-02-08

Recalling FirmGE Medical Systems, SCS
Recall StatusOpen, Classified
Product CodeMUE
Date Initiated2023-12-26
Product Quantity180 units (60 US; 120 OUS)

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.

Firm Action

GE HealthCare will, without charge, remedy the defect or bring the product into compliance. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Us Nationwide-Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211215SenoBright HDGE Healthcare · 2021-06-22K193334Pristina Serena BrightGE Healthcare · 2020-05-15K182951Pristina Serena 3DGE Healthcare · 2019-01-18K173576Pristina SerenaGE Healthcare · 2018-05-14K162268Senographe PristinaGE Healthcare · 2016-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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