FDA Recall Terminated

Centricity 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.

Recall: Z-1782-2017 · Initiated February 18, 2013

Recall

Recall Number
Z-1782-2017
Event Number
64545
Firm
Ge Medical Systems Information T
FEI Number
3004526608
Product Code
LLZ
Status
Terminated
Root Cause
Software design
Initiated
February 18, 2013
Posted
April 11, 2017
Terminated
July 31, 2017
Address
540 W Northwest Hwy, Barrington, IL, 60010-3051

Description

Centricity 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.

Reason

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.

Action

Firm 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.

Distribution

Nationwide, Worldwide

Quantity

118