Device recall
Z-2096-2021: AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor…
FDA device recall · Class II · Mediana Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2096-2021 |
|---|---|
| Recall event | 88166 |
| Product | AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. |
| Product code | DXN |
| Recalling firm | Mediana Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2022 |
| 510(k) numbers | K200434 |
| FEI number | 3003591740 |
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