Device recall
Z-1161-2021: ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular…
FDA device recall · Class I · Acist Medical Systems
Key facts
| Recall number (Z-number) | Z-1161-2021 |
|---|---|
| Recall event | 87254 |
| Product | ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated… |
| Product code | OBJ |
| Recalling firm | Acist Medical Systems |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 30, 2023 |
| 510(k) numbers | K193183 |
| FEI number | 3001726808 |
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