FDA DeviceClass IINotable

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

Date: 2026-07-01
Brand: GE Medical Systems SCS
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

340 servers

View original recall →
Share:

Related Recalls

2026-07-22 · FDA_DEVICE
FDA Recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma exter
Orthofix U.S. LLC
2026-07-22 · FDA_DEVICE
FDA Recall: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
ICU Medical, Inc.
2026-07-22 · FDA_DEVICE
FDA Recall: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Argon Medical Devices, Inc
2026-07-22 · FDA_DEVICE
FDA Recall: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Medline Industries, LP