FDAMay 8, 2026device

GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems scs

UPCs

00840682102384

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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