Medical device recalls Moderate risk

Ge Medical Systems Information T recalls Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical ima…

Recall date
February 18, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1782-2017
FDA classification
Class II
Brand / firm
Ge Medical Systems Information T
Sold / distributed
Nationwide, Worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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