Device recall
Z-2308-2021: Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during…
FDA device recall · Class II · Hitachi Healthcare Americas Corporation
Key facts
| Recall number (Z-number) | Z-2308-2021 |
|---|---|
| Recall event | 88367 |
| Product | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures |
| Product code | IYN |
| Recalling firm | Hitachi Healthcare Americas Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K173739, K183456 |
| FEI number | 1528028 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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