Class 2 Device Recall Vivid E9, Vivid E95

• Date Initiated by Firm: May 02, 2024
• Date Posted: July 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2316-2024
• Recall Event ID: 94772
• 510(K)Number: K150087
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
• Code Information: a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002
• Recalling Firm/ Manufacturer: GE Vingmed Ultrasound As; Strandpromenaden 45; Horten Norway
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN