Z-2317-2024 Class II Ongoing

Recalled by GE Vingmed Ultrasound As — Horten, N/A

Recall Details

Product Type
Devices
Report Date
July 17, 2024
Initiation Date
May 2, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

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.

Distribution Pattern

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

Code Information

a) H45041SW, UDI/DI *, Serial Numbers: 001423S70