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Recall Observatory FDA recall evidence

Device product

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

Z-2316-2024

May 02, 2024

Class II

Product summary

Firm
GE Vingmed Ultrasound As
Event
Event 94772
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-2316-2024

Official wording

Reason: 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.

Code information: a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.