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U.S. Department of Health and Human Services

Class 2 Device Recall Senographe Pristina with Efficiency Suite 2

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  Class 2 Device Recall Senographe Pristina with Efficiency Suite 2 see related information
Date Initiated by Firm December 26, 2023
Date Posted February 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-0862-2024
Recall Event ID 93837
510(K)Number K162268  K182951  K173576  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/
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 2
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 and Original Applicant = GE HEALTHCARE