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FDA
Food and Drug Administration · Recall Z-2553-2026 · May 8, 2026

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

GE Medical Systems SCS

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. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

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

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model REF# (01)00840682102384(10)AWS03D02E6D5Model GTIN Number 00840682102384UPC 00840682102384

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.