Ge Medical Systems Scs: System, Image Processing, Radiological
Recall Summary GE Healthcare's AW Server 3.2 ext. 6.5 medical imaging system has a software glitch where launching an application to view a patient's images may instead open the previous patient's images without any warning or error message. This could cause doctors to review, report, or make clinical decisions based on the wrong patient's medical images, potentially leading to misdiagnosis or incorrect treatment. The affected system is distributed worldwide, including throughout the United States.
- Recalling firm
- 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...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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),...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0955b88e-1b08-41eb-8d5b-bbccd0aabcd6