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Class 2 Device Recall GE |
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Date Initiated by Firm |
March 28, 2023 |
Date Posted |
May 02, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1500-2023 |
Recall Event ID |
92062 |
510(K)Number |
K123174
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Product Classification |
System, image processing, radiological - Product Code LLZ
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Product |
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System |
Code Information |
No UDI/DI for these products:
a) 2066908-061, Product ID Numbers: HC3062-Centricity Universal Viewer-01462397;
b) 2066908-077, Product ID Numbers: YP3150-Centricity Universal Viewer-01639018;
c) 2066908-086, Product ID Numbers: 100707-1-Centricity Universal Viewer-00558649, 9842-4-Centricity Universal Viewer-19386293;
d) 2066908-111, Product ID Numbers: 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785;
e) 2066908-123, Product ID Numbers: 4705-1-Centricity Universal Viewer-02398923;
f) 2066908-136, Product ID Numbers: 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, ZA2533-Centricity Universal Viewer-00116577, 280801-Centricity Universal Viewer-19737221;
g) 2066908-150, Product ID Numbers: 100759-1-Centricity Universal Viewer-02360986, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, RU9761-UW PACS-IW UP TO 10K-02336112
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Recalling Firm/ Manufacturer |
GE Healthcare 500 W Monroe St Chicago IL 60661-3671
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For Additional Information Contact |
GE HealthCare Service 800-437-1171
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Manufacturer Reason for Recall |
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
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FDA Determined Cause 2 |
Other |
Action |
GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction. |
Quantity in Commerce |
17 units |
Distribution |
Worldwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE
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