Horten, N/A, Norway
GE Vingmed Ultrasound As recalls
2 recalls recorded since 2018, most recently on 2 May 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 May 2024
- 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.
- Distribution
- US: IL, MA, NM, NY, OK,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2317-2024, Z-2316-2024
- GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
- GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Ongoing Class II Medical devices
- Recall started
- 30 May 2023
- Reason
- GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2126-2023, Z-2127-2023, Z-2125-2023, Z-2124-2023
- GE Healthcare Vivid S60N, ultrasound device
- GE Healthcare Vivid S70N, ultrasound device
- GE Healthcare Vivid S70, ultrasound device
- GE Healthcare Vivid S60, ultrasound device
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.