GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Brand
GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway
Lot Codes / Batch Numbers
a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159, b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002
Products Sold
a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002
GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway is recalling GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA due to GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/02/2024 via letter delivered by traceable means. The notice explained the problem with the device, potential safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your device in accordance with the User Manuals, specifically: 1. After selecting a patient in the DICOM Modality Worklist, make sure to review and confirm that the patient demographics shown on the ultrasound scanner screen during the exam are from the intended patient. 2. In the scenarios where the incorrect and/or actual patient already exists in the patient archive, a Patient Match dialog can be shown to inform you about patient information inconsistency. Make sure to review the patient demographics properly. 3. To reduce the probability of occurrence of the issue, reduce the size of the DICOM Worklist search by: a) Setting Max. Results to 75 in the Worklist dataflow Config dialog (available by selecting Config | Connectivity | Dataflow | Worklist* | Inputs | DicomWorklist | Properties) and/or b) Configuring the DICOM Worklist server to automatically delete Scheduled Procedure Steps that have been performed on the ultrasound scanner. If this option is not available on your DICOM Worklist server, make sure to manually clear all Scheduled Procedure Steps that have been performed from the DICOM Worklist on a regular basis (e.g., every day). *The actual instructions on how to perform this step depends on which DICOM Worklist server is used in your department. Consult your IT department to find out how to perform the step. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." "GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, MA, NM, NY, OK
Page updated: Jan 10, 2026