FDA recall Z-2316-2024

Product

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

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

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

Key facts

Status

Ongoing

Initiation date

2024-05-02

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horten, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2316-2024