FDA Medical Device Recalls (openFDA)
GE Vingmed Ultrasound As: GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
- Recall number
- Z-2316-2024
- Recalling firm
- GE Vingmed Ultrasound As
- Product
- GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
- Status
- Open, Classified
- Initiated
- 2024-05-02
- Posted
- 2024-07-05
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- 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."
- Quantity
- 7 units
- Distribution
- US: IL, MA, NM, NY, OK,
- Lot, serial or model codes
- a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002
- 510(k) numbers
- ["K150087"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3002808457
- Firm city
- Horten
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28