GE Medical Systems SCS: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems SCS
- Product
- GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-05-08
- Code info
- REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
- Product quantity
- 340 servers
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Buc
- State
- N/A
- Country
- France
- Event id
- 99042
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