FDA Device recall Z-2316-2024
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB by Ge Vingmed Ultrasound As, citing GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2316-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-02 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Vingmed Ultrasound As |
| Distribution | IL, MA, NM, NY, OK |
Product
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Reason
GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.
Identifiers
| code_info | a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2316-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.