Z-2316-2024Class II

GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA

Name: Z-2316-2024 GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Creator: GE Vingmed Ultrasound As
Published: 2024-05-02
License: https://open.fda.gov/license/

GE Vingmed Ultrasound AS / initiated 2024-05-02 / Open, Classified / root cause: design

FDA source

GE Vingmed Ultrasound As began a recall of GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA on 2024-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2316-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-02
Posted: 2024-07-05
Recalling firm: GE Vingmed Ultrasound AS
Product: GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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 tag: design
FDA 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 in commerce: 7 units
Distribution: US: IL, MA, NM, NY, OK,
Product codes and lots: a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2316-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2316-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05
Z-2317-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05

Product code IYN

K150087Class IIVivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS / cleared 2015-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)