GE Healthcare Vivid S60N — Class II medical device recall Z-2126-2023
Ongoing recall by GE Vingmed Ultrasound As, reported 2023-07-19. GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If th
| Recall number | Z-2126-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Vingmed Ultrasound As, Horten, N/A, Norway |
| Recall initiated | 2023-05-30 |
| Classified | 2023-07-10 |
| Reported by FDA | 2023-07-19 |
Product
GE Healthcare Vivid S60N, ultrasound device
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.