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Recall Observatory FDA recall evidence

Device product

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

Z-2317-2024

May 02, 2024

Class II

Product summary

Firm
GE Vingmed Ultrasound As
Event
Event 94772
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2317-2024

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

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.