Recall Z-2125-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Vingmed Ultrasound As
GE Healthcare Vivid S70, ultrasound device
| Date | Jul 10, 2023 (initiated May 30, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 14 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System Ge Medical Systems Israel , Ltd., Oct 10, 2014 |