Recall Z-2553-2026— GE Medical Systems SCS

Name: FDA recall Z-2553-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems SCS, initiated 2026-05-08. It names one FDA 510(k) clearance: K081985. Product: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System. Reason: 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..

Recalling firm: GE Medical Systems SCS
Classification: Class II
Status: Ongoing
Initiated: 2026-05-08
Firm location: Buc, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K081985 — AW SERVERGe Medical Systems, LLC·cleared 2008-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.