FDAFDA · Food and drugs·Recall number Z-2316-2024
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Published July 17, 2024 · Recall initiated: May 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Vingmed Ultrasound As
- Distributor
- US: IL, MA, NM, NY, OK,
- Lot
- a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Norway
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.