Recall Z-2553-2026 ยท LLZ System, Image Processing, Radiological
GE Medical Systems SCS
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
| Date | Jun 24, 2026 (initiated May 8, 2026) |
| Status | Open, Classified |
| 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 tre |
| Root cause | Software design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 5/8/2026 by letter delivered via traceable means. The notice explained the issue, potential risk to patient, and requested the following: "Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use the device by following the instructions below: " Ensure that users verify the correct patient identity (including name, patient ID, and date of birth) and confirm that the selected study matches the intended patient and clinical context prior to reviewing or interpre |
| Quantity | 340 servers |
| 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), Lithuania, Mo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081985 | AW SERVER Ge Medical Systems, LLC, Sep 25, 2008 |