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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity Web Diagnostic (WebDx)

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 Class 2 Device Recall GE Centricity Web Diagnostic (WebDx)see related information
Date Initiated by FirmFebruary 18, 2013
Date PostedApril 11, 2017
Recall Status1 Terminated 3 on July 31, 2017
Recall NumberZ-1782-2017
Recall Event ID 64545
510(K)NumberK083018 
Product Classification System, image processing, radiological - Product Code LLZ
ProductCentricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
Code Information Versions 1.0, 1.1, 2.0, 2.1
FEI Number 3004526608
Recalling Firm/
Manufacturer		 Ge Medical Systems Information T
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact
1800-437-1171
Manufacturer Reason
for Recall		It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
FDA Determined
Cause 2		Software design
ActionFirm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue.
Quantity in Commerce118
DistributionNationwide, Worldwide
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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