Device product
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Z-2317-2024
Product summary
- 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
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.