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/ 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 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
|