GE Vingmed Ultrasound As: Device Recall

Recall #Z-2316-2024 · 05/02/2024

Class II: Risk

Recall Details

Recall Number: Z-2316-2024
Classification: Class II
Product Type: Device
Recalling Firm: GE Vingmed Ultrasound As
Status: Ongoing
Date Initiated: 05/02/2024
Location: Horten, N/A, Norway
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7 units

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.

Product Description

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

Distribution Pattern

US: IL, MA, NM, NY, OK,

Other Recalls by GE Vingmed Ultrasound As

Class II: Risk 05/02/2024

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.

View all recalls by GE Vingmed Ultrasound As →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.