United StatesGE Healthcare AW Server 3.2 ext.6.5 radiological image processing system (REF# (01)00840682102384(10)AWS03D02E6D5, GTIN 00840682102384) is affected. It was recalled because a context synchronization issue can cause an interactive application to open the previous patient’s exam instead of the intended one with no warning, which could lead clinicians to review or report images for the wrong patient and result in misdiagnosis, incorrect clinical decisions, or delayed/incorrect treatment.
What's being recalled
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Recalling firm: GE Medical Systems SCS, Buc, N/A, France.
How to identify it
REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada