Recall Z-2126-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Vingmed Ultrasound As
GE Healthcare Vivid S60N, 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. |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170878 | Vivid S60N, Vivid S70N GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Jun 14, 2017 |
| K182450 | Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics, Oct 19, 2018 |
| K200497 | Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics, Jul 16, 2020 |
| K211216 | Vivid S60N / Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics, Jun 9, 2021 |
| K220619 | Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics, Jul 15, 2022 |
| K223832 | Vivid S60N, Vivid S70N Ge Medical System Ultrasound and Primary Care Diagnostics, Feb 16, 2023 |