FDA Device recall Z-2553-2026
GE Healthcare AW Server 3.2 ext.6.5
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of GE Healthcare AW Server 3.2 ext.6.5 by Ge Medical Systems Scs, citing 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 launche….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2553-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-08 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems Scs |
| Distribution | US |
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 treatment.
Identifiers
| code_info | REF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2553-2026%22
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