Device recall
Z-2111-2021: Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging…
FDA device recall · Class II · Caption Health
Key facts
| Recall number (Z-number) | Z-2111-2021 |
|---|---|
| Recall event | 88101 |
| Product | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) |
| Product code | QIH |
| Recalling firm | Caption Health |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2023 |
| 510(k) numbers | K200621 |
| FEI number | 3016665037 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database