Device recall
Z-1768-2017: Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem…
FDA device recall · Class II · Nihon Kohden America Inc
Key facts
| Recall number (Z-number) | Z-1768-2017 |
|---|---|
| Recall event | 76723 |
| Product | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA). |
| Product code | MHX |
| Recalling firm | Nihon Kohden America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2017 |
| 510(k) numbers | K151080 |
| FEI number | 2080783 |
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