Device recall
Z-0189-2018: Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-0189-2018 |
|---|---|
| Recall event | 78569 |
| Product | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF… |
| Product code | OBJ |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2023 |
| 510(k) numbers | K071554, K123898 |
| FEI number | 2939520 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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