FDAClass II · Medical device · Recalled July 1, 2026

GE Healthcare AW Server 3 recall — GE Medical Systems SCS

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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2553-2026
Brand: GE Medical Systems SCS
Classification: Class II
Units affected: 340 servers
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

GE Healthcare AW Server 3

Companies & origin

Recalling firm location: Buc, N/A, France
Firm address: 283 rue de la Miniere, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Distribution: Worldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam.
Firm notified the public via: Letter
FDA event ID: 99042
Recall initiated: May 8, 2026
FDA classified: June 24, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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