GE Vingmed Ultrasound As: Device Recall

Recall #Z-2317-2024 · 05/02/2024

Class II: Risk

Recall Details

Recall Number
Z-2317-2024
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
1 unit

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 S70, H45041SW

Distribution Pattern

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

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.