Class 2 Device Recall Senographe Pristina with Efficiency Suite 2

• Date Initiated by Firm: December 26, 2023
• Date Posted: February 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0862-2024
• Recall Event ID: 93837
• 510(K)Number: K162268 K173576 K182951 K193334 K211215
• Product Classification: Full field digital, system, x-ray, mammographic - Product Code MUE
• Product: Senographe Pristina
• Code Information: GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
• Recalling Firm/ Manufacturer: GE Medical Systems, SCS; 283 rue de la Miniere; Buc France
• For Additional Information Contact: Stephanie Cass ; 1- 3070 4024
• Manufacturer 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• 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.
• Quantity in Commerce: 180 units (60 US; 120 OUS)
• Distribution: Us Nationwide-Worldwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MUE