GE Healthcare Vivid S70N, ultrasound device
FDA device recall Z-2127-2023 · posted 2023-07-10 · Open, Classified
Recall details
- Recalling firm
- GE Vingmed Ultrasound As
- 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.
- 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- IYN
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-05-30
- Date posted
- 2023-07-10
- Location
- Horten, Norway
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vivid S60N, Vivid S70N (K223832) | Ge Medical System Ultrasound and Primary Care Diagnostics | 2023-02-16 |
| Vivid S60N, Vivid S70N (K220619) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-07-15 |
| Vivid S60N / Vivid S70N (K211216) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-06-09 |
| Vivid S60N, Vivid S70N (K200497) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-07-16 |
| Vivid S60N, Vivid S70N (K182450) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018-10-19 |
| Vivid S60N, Vivid S70N (K170878) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-14 |