Device recall
Z-1215-2023: epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1215-2023 |
|---|---|
| Recall event | 91639 |
| Product | epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583 |
| Product code | CHL |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200107 |
| FEI number | 3002637618 |
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