GE Medical Systems SCS — GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 8, 2026
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.
What's affected?
- Product
- GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
- Lot code
- REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
Additional details
REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 340 servers.
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