FDA DevicesClass II
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Published: July 1, 2026Recall ID: Z-2553-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Additional Source Details
| Field | Value |
|---|---|
| City | Buc |
| State | N/A |
| Event id | 99042 |
| Address 1 | 283 rue de la Miniere |
| Address 2 | N/A |
| Code info | REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384 |
| Postal code | N/A |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 340 servers |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260508 |
| Initial firm notification | Letter |
| Center classification date | 20260624 |
Overview
- Recalling FirmGE Medical Systems SCS
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.