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

Class II
Recalling firm
GE Medical Systems SCS
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.
Affected products (lot / model / serial)
REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Units affected
340 servers
Distribution pattern
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 location
Buc, N/A, France
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2553-2026
Recall initiated
May 8, 2026
FDA classification date
June 24, 2026
FDA report date
July 1, 2026
FDA event ID
99042
Last updated on HTM Vibe
July 23, 2026
View on openFDA