FDA Enforcement
Class II
Ongoing
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Recall: Z-2317-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2317-2024
- Event ID
- 94772
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Vingmed Ultrasound As
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- May 2, 2024
- Classification Date
- July 5, 2024
- Address
- Strandpromenaden 45, N/A, Horten, N/A, N/A, Norway
Description
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
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 Info
a) H45041SW, UDI/DI *, Serial Numbers: 001423S70
Distribution
US: IL, MA, NM, NY, OK,
Quantity
1 unit