GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5

Recalling company

GE Medical Systems SCS

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 8, 2026

Reported

Jul 1, 2026

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.

Status

Ongoing

Quantity

340 servers

Lot / codes

REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384

Company location

Buc, N/A

Recall type

Voluntary: Firm initiated

Recall number

Z-2553-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2553-2026 in the FDA Enforcement Report. Also see FDA recall press releases.