GE Healthcare AW Server 3 — Class II medical device recall Z-2553-2026
Ongoing recall by GE Medical Systems SCS, reported 2026-07-01, distributed nationwide. GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selec
| Recall number | Z-2553-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems SCS, Buc, N/A, France |
| Recall initiated | 2026-05-08 |
| Classified | 2026-06-24 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BG, BR, CA, CH, CL, CO, DE, DK, DZ, ES, FI, FR, GB, GR, HR, HU, ID, IL, IN, IQ, IT, JP, KR, LT, MA, NL, NO, NP, NZ, PK, PL, PT, RO, RU, SA, SE, SK, TH, TN, TW, VN, ZA |
| Quantity | 340 servers |
| UPC / GTIN / UDI-DI | 00840682102384 |
Product
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2553-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.