GE Healthcare Vivid S60N, ultrasound device
This recall is currently active, issued July 10, 2023. It was issued by Ge Vingmed Ultrasound As Strandpromenaden 45 Horten Norway.
- Recall Initiated
- May 30, 2023
- Posted
- July 10, 2023
- Recall Number
- Z-2126-2023
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
Software versions: v203, v204, v205, v206
Root Cause
Process design
Action Taken
GE Healthcare sent an Urgent Medical Device Correction notice to its consignees on 05/30/2023 by mail (traceable means). The notice explained the problem with the instrument and provided the following: "You can continue to use your device. Please follow clinical practice guidelines, which include having a backup imaging plan when performing time-critical examinations or image-guided interventions." The devices will be corrected at no charge to the consignee.