FDA-Device2026-07-01Class II

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

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.

Sold states

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.

Affected count

340 servers

Manufactured in

283 rue de la Miniere, N/A, Buc, N/A, France

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2026

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